scholarly journals Effects of Intravenous Zoledronate on Bone Turnover and Bone Density Persist for at Least Five Years in HIV-Infected Men

2012 ◽  
Vol 97 (6) ◽  
pp. 1922-1928 ◽  
Author(s):  
Mark J. Bolland ◽  
Andrew Grey ◽  
Anne M. Horne ◽  
Simon E. Briggs ◽  
Mark G. Thomas ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Bone Turnover ◽  
Controlled Trial ◽  
Mineral Density ◽  
Annual Dose ◽  
Double Blind ◽  
Duration Of Action ◽  
Total Hip ◽  
Hip Bmd ◽  
Total Body

Context: In HIV-infected men, the antiresorptive effects of zoledronate persist for at least 2 yr after the second annual dose. Objective: Our objective was to determine the duration of action of zoledronate in men. Design and Setting: This was 4-yr extension of a 2-yr, double-blind, randomized, placebo-controlled trial at an academic research center. Participants: Participants included 43 HIV-infected men with bone mineral density (BMD) T score below −0.5, 35 of whom entered the extension study. Intervention: Intervention was annual administration of 4 mg iv zoledronate or placebo at baseline and 1 yr and no intervention subsequently. Main Outcome Measures: We evaluated changes in the bone turnover markers, serum osteocalcin and serum C-telopeptide (CTx), and changes in BMD at the lumbar spine, total hip, and total body. Results: There was no time × treatment interaction between 1 and 5 yr after the second zoledronate dose for osteocalcin or CTx (P > 0.4) or any BMD site (P > 0.7). Between 1 and 5 yr after the second dose, on average, osteocalcin was 41% lower (95% confidence interval = 19–62%; P < 0.001), CTx 52% lower (33–71%; P < 0.001), lumbar spine BMD 3.7% greater (0.3–7.0%; P = 0.03), total hip BMD 2.3% greater (0.3–4.3%; P = 0.02), and total body BMD 2.5% greater (0.8–4.1%; P = 0.004) in the zoledronate group than the placebo group. Five years after the second dose, the between-groups differences were 38% (13–62%) for osteocalcin, 49% (20–77%) for CTx, 3.5% (0.7–6.7%) for lumbar spine BMD, 3.4% (1.4–5.4%) for total hip BMD, and 1.6% (0.2–3.1%) for total body BMD. Conclusion: The effects of two annual 4-mg doses of zoledronate in men persist for at least 5 yr after the second dose. Larger trials assessing the antifracture efficacy of less frequent dosing of zoledronate are justified.

scholarly journals A Comparison of the Effects of Raloxifene and Estrogen on Bone in Postmenopausal Women1

2000 ◽  
Vol 85 (6) ◽  
pp. 2197-2202
Author(s):  
Karen M. Prestwood ◽  
Michele Gunness ◽  
Douglas B. Muchmore ◽  
Yili Lu ◽  
Mayme Wong ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Bone Turnover ◽  
Postmenopausal Women ◽  
Biochemical Markers ◽  
Mineral Density ◽  
Bone Formation Rate ◽  
Markers Of Bone Turnover ◽  
Bone Biopsies ◽  
Hip Bmd ◽  
Total Body

Raloxifene HCl, a selective estrogen receptor modulator, has been shown to increase bone mineral density (BMD) and decrease biochemical markers of bone turnover in postmenopausal women without stimulatory effects on the breast and uterus. However, it is not known whether the changes in BMD and bone turnover are associated with changes at the tissue level, nor how changes with raloxifene compare with estrogen. In this randomized, double blind study, we evaluated the effects of raloxifene (Evista, 60 mg/day) or conjugated equine estrogens (CEE; Premarin, 0.625 mg/day) on bone architecture, bone turnover, and BMD. Iliac crest bone biopsies were obtained at baseline and at the end of the study after double tetracycline labeling and were analyzed for standard histomorphometric indexes. Serum and urinary biochemical markers of bone turnover were measured at baseline and at 4, 10, 18, and 24 weeks of treatment. Total body, lumbar spine, and hip BMD were measured at baseline and at the end of the study by dual energy x-ray absorptiometry. Activation frequency and bone formation rate/bone volume were significantly decreased from baseline in the CEE, but not in the raloxifene, group. Bone mineralization did not change in either group. Most markers of bone resorption and formation decreased in both groups, but to a greater degree in the CEE group (P < .05). Total body and lumbar spine BMD increased from baseline in both groups, with a greater increase in the CEE group (P< 0.05). Hip BMD significantly increased from baseline in the raloxifene group, but the change was not different from that in the CEE group. These results suggest that raloxifene reduces bone turnover and increases bone density, although to a lesser extent than CEE. Thus, raloxifene is an alternative to CEE for the prevention and treatment of osteoporosis in postmenopausal women.

Prevention of Aromatase Inhibitor–Induced Bone Loss Using Risedronate: The SABRE Trial

2010 ◽  
Vol 28 (6) ◽  
pp. 967-975 ◽  
Author(s):  
Catherine Van Poznak ◽  
Rosemary A. Hannon ◽  
John R. Mackey ◽  
Mario Campone ◽  
Justus P. Apffelstaedt ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Postmenopausal Women ◽  
Fragility Fracture ◽  
Group Treatment ◽  
Mineral Density ◽  
Double Blind ◽  
Total Hip ◽  
Hormone Receptor Positive ◽  
Hip Bmd ◽  
To Receive

PurposeTo investigate the management of bone health in women with early breast cancer (EBC) who were scheduled to receive anastrozole.Patients and MethodsPostmenopausal women with hormone receptor–positive EBC were assigned to one of three strata by risk of fragility fracture. Patients with the highest risk (H) received anastrozole 1 mg/d plus risedronate 35 mg/wk orally. Patients with moderate-risk (M) were randomly assigned in a double-blind manner to anastrozole and risedronate (A + R) or to anastrozole and placebo (A + P). Patients with lower-risk (L) received anastrozole (A) alone. Calcium and vitamin D were recommended for all patients. Lumbar spine and total hip bone mineral density (BMD) were assessed at baseline, 12 months, and 24 months.ResultsAt 24 months, in the M group, treatment with A + R resulted in a significant increase in lumbar spine and total hip BMD compared with A + P treatment (2.2% v −1.8%; treatment ratio, 1.04; P < .0001; and 1.8% v −1.1%; treatment ratio, 1.03; P < .0001, respectively). In the H stratum, lumbar spine and total hip BMD increased significantly (3.0%; P = .0006; and 2.0%; P = .0104, respectively). Patients in the L stratum showed a significant decrease in lumbar spine BMD (−2.1%; P = .0109) and a numerical decrease in total hip BMD (−0.4%; P = .5988). Safety profiles for anastrozole and risedronate were similar to those already established.ConclusionIn postmenopausal women at risk of fragility fracture who were receiving adjuvant anastrozole for EBC, the addition of risedronate at doses established for preventing and treating osteoporosis resulted in favorable effects in BMD during 24 months.

scholarly journals The Antiresorptive Effects of a Single Dose of Zoledronate Persist for Two Years: A Randomized, Placebo-Controlled Trial in Osteopenic Postmenopausal Women

2009 ◽  
Vol 94 (2) ◽  
pp. 538-544 ◽  
Author(s):  
Andrew Grey ◽  
Mark J. Bolland ◽  
Diana Wattie ◽  
Anne Horne ◽  
Greg Gamble ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Bone Turnover ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Proximal Femur ◽  
Controlled Trial ◽  
Mineral Density ◽  
Markers Of Bone Turnover ◽  
Total Body

Abstract Context: Annual iv administration of 5 mg zoledronate decreases fracture risk. The optimal dosing interval of 5 mg zoledronate is not known. Objective: Our objective was to determine the duration of antiresorptive action of a single 5-mg dose of iv zoledronate. Design, Setting, and Participants: We conducted a double-blind, randomized, placebo-controlled trial over 2 yr at an academic research center, in a volunteer sample of 50 postmenopausal women with osteopenia. Intervention: Intervention included 5 mg zoledronate. Main Outcome Measures: Biochemical markers of bone turnover and bone mineral density of the lumbar spine, proximal femur, and total body. Results: Compared with placebo, zoledronate treatment decreased mean levels of each of four markers of bone turnover by at least 38% (range 38–45%) for the duration of the study (P &lt; 0.0001 for each marker). After 2 yr, bone mineral density was higher in the zoledronate group than the placebo group by an average of 5.7% (95% confidence interval = 4.0–7.4) at the lumbar spine, 3.9% (2.2–5.7) at the proximal femur, and 1.7% (0.8–2.5) at the total body (P &lt; 0.0001 for each skeletal site). Between-groups differences in markers of bone turnover and bone mineral density were similar at 12 and 24 months. Mild secondary hyperparathyroidism was present throughout the study in the zoledronate group. Conclusion: The antiresorptive effects of a single 5-mg dose of zoledronate are sustained for at least 2 yr. The magnitudes of the effects on markers of bone turnover and bone mineral density are comparable at 12 and 24 months. Administration of zoledronate at intervals of up to 2 yr may be associated with antifracture efficacy; clinical trials to investigate this possibility are justified.

scholarly journals Effects of Teriparatide in Postmenopausal Women with Osteoporosis on Prior Alendronate or Raloxifene: Differences between Stopping and Continuing the Antiresorptive Agent

2009 ◽  
Vol 94 (10) ◽  
pp. 3772-3780 ◽  
Author(s):  
Felicia Cosman ◽  
Robert A. Wermers ◽  
Christopher Recknor ◽  
Karen F. Mauck ◽  
Li Xie ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Bone Turnover ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Mineral Density ◽  
Total Hip ◽  
Hip Bmd ◽  
Switch Group

Objective: The aim of the study was to assess adding vs. switching to teriparatide 20μg/d in patients on alendronate or raloxifene. Design: We conducted a randomized, open-label trial. Patients and Interventions: Postmenopausal women with osteoporosis on alendronate or raloxifene for at least 18 months added teriparatide (Add groups) or switched to teriparatide (Switch groups) for 18 months. Main Outcome Measures: We measured bone turnover markers (BTM) and bone mineral density (BMD). Results: In the alendronate stratum, increases in BTM were smaller in the Add vs. Switch group [6-month PINP (64 vs. 401%); bone ALP (15 vs. 71%); βCTX (27 vs. 250%); all P &lt; 0.001]. However, at 6 months, total hip BMD increased more in the Add vs. Switch group (1.4 vs. −0.8%; P = 0.002). In the Add vs. Switch group, 18-month BMD increments were higher in lumbar spine (8.4 vs. 4.8%; P = 0.003) and total hip (3.2 vs. 0.9%; P = 0.02), but not in femoral neck (2.7 vs. 2.3%; P = 0.75). In the raloxifene stratum, increases in BTM were also smaller in the Add vs. Switch group [6-month PINP (131 vs. 259%; P &lt; 0.001), bone ALP (31 vs. 44%; P = 0.035), and βCTX (67 vs. 144%; P = 0.001)]. At 6 months, total hip BMD increase was greater in the Add vs. Switch group (1.8 vs. 0.5%; P = 0.028). At 18 months, increases in lumbar spine (9.2 vs. 8.1%), total hip (2.8 vs. 1.8%), and femoral neck (3.8 vs. 2.2%) were not significantly different between groups. Conclusions: In women with osteoporosis treated with antiresorptives, greater bone turnover increases were achieved by switching to teriparatide, whereas greater BMD increases were achieved by adding teriparatide. In patients treated with alendronate or raloxifene, adding teriparatide results in a greater bone mineral density response, and appears to be at least as safe as switching to teriparatide.

scholarly journals Effect of once-daily fluticasone furoate/vilanterol versus vilanterol alone on bone mineral density in patients with COPD: a randomized, controlled trial

2020 ◽  
Vol 14 ◽  
pp. 175346662096514
Author(s):  
Francois Maltais ◽  
Isabelle Schenkenberger ◽  
Pascal L. M. L. Wielders ◽  
Juan Ortiz de Saracho ◽  
Kenneth Chinsky ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Bone Mineral ◽  
Smoking History ◽  
Mineral Density ◽  
Fluticasone Furoate ◽  
Treatment Difference ◽  
Total Hip ◽  
Copd Exacerbations ◽  
Hip Bmd

Background: The relationship between inhaled corticosteroids and bone mineral density (BMD) remains uncertain despite extensive research. Methods: This was an international, multicenter, randomized, double-blind, parallel-group, 3-year noninferiority study. Patients with chronic obstructive pulmonary disease (COPD) (⩾40 years of age; smoking history ⩾10 pack years) and at least one native hip evaluable for BMD were enrolled and randomized 1:1, stratified by sex, to treatment with vilanterol (VI) 25 µg or fluticasone furoate/vilanterol (FF/VI) 100 µg/25 µg. BMD measurements were taken via dual-energy X-ray absorptiometry every 6 months. The primary endpoint was assessment of the noninferiority of change from baseline in total hip BMD per year at the −1% noninferiority level. Change from baseline in BMD at the lumbar spine and BMD measurements by sex were secondary endpoints. Incidences of COPD exacerbations and bone fractures throughout the study were also recorded. Results: Of 283 randomized patients, 170 (60%) completed the study. Noninferiority was demonstrated for FF/VI versus VI with regards to change from baseline in total hip BMD per year, with changes of −0.27% and 0.18%, respectively, and a treatment difference of −0.46% per year [95% confidence interval (CI) −0.97 to 0.06]. The treatment difference for FF/VI versus VI regarding lumbar spine BMD was −0.51% per year (95% CI −1.11 to 0.10). COPD exacerbations and bone fracture rates were similar between treatment groups. Conclusion: FF/VI showed noninferiority to VI for change from baseline in total hip BMD per year, when assessed at the −1% noninferiority margin in a combined sample of men and women with COPD. The reviews of this paper are available via the supplemental material section.

scholarly journals Effect of Calcium or 25OH Vitamin D3 Dietary Supplementation on Bone Loss at the Hip in Men and Women over the Age of 60*

2000 ◽  
Vol 85 (9) ◽  
pp. 3011-3019 ◽  
Author(s):  
Munro Peacock ◽  
Guangda Liu ◽  
Mark Carey ◽  
Ronald McClintock ◽  
Walter Ambrosius ◽  
...  
Keyword(s):  
Bone Loss ◽  
Bone Turnover ◽  
Secondary Hyperparathyroidism ◽  
Vitamin D3 ◽  
Bone Structure ◽  
Controlled Trial ◽  
Drop Out ◽  
Mineral Density ◽  
Serious Adverse Events ◽  
Double Blind

Abstract Dietary supplements that prevent bone loss at the hip and that can be applied safely in the elderly are likely to reduce hip fractures. A daily dietary supplement of 750 mg calcium or 15 μg 25OH vitamin D3 on bone loss at the hip and other sites, bone turnover and calcium-regulating hormones were studied over 4 yr in elderly volunteers using a randomized, double-blind, placebo-controlled trial. Bone mineral density (BMD) was measured by dual x-ray absorptiometry and bone structure by radiographs. Calcium biochemistry and bone turnover markers were measured in blood and urine. The 316 women entering the trial had a mean age of 73.7 yr and the 122 men of 75.9 yr. Baseline median calcium intake was 546 mg/day, and median serum 25OH vitamin D3 was 59 nmol/L. On placebo, loss of BMD at total hip was 2% and femoral medulla expansion was 3% over 4 yr. Calcium reduced bone loss, secondary hyperparathyroidism, and bone turnover. 25OH vitamin D3 was intermediate between placebo and calcium. Fracture rates and drop-out rates were similar among groups, and there were no serious adverse events with either supplement. A calcium supplement of 750 mg/day prevents loss of BMD, reduces femoral medullary expansion, secondary hyperparathyroidism, and high bone turnover. A supplement of 15 μg/day 25OH vitamin D3 is less effective, and because its effects are seen only at low calcium intakes, suggests that its beneficial effect is to reverse calcium insufficiency.

scholarly journals Reduction in femoral neck and total hip bone mineral density following hospitalisation for diabetes-related foot ulceration

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Marcel M. Nejatian ◽  
Salar Sobhi ◽  
Blake N. Sanchez ◽  
Kathryn Linn ◽  
Laurens Manning ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Femoral Neck ◽  
Bone Mineral ◽  
Fat Mass ◽  
Mineral Density ◽  
Contralateral Limb ◽  
Foot Ulceration ◽  
Total Hip ◽  
Hip Bmd

AbstractManagement of diabetes-related foot ulceration (DFU) includes pressure offloading resulting in a period of reduced activity. The metabolic effects of this are unknown. This study aims to investigate changes in bone mineral density (BMD) and body composition 12 weeks after hospitalisation for DFU. A longitudinal, prospective, observational study of 22 people hospitalised for DFU was conducted. Total body, lumbar spine, hip and forearm BMD, and total lean and fat mass were measured by dual-energy X-ray absorptiometry (DXA) during and 12 weeks after hospitalisation for DFU. Significant losses in total hip BMD of the ipsilateral limb (− 1.7%, p < 0.001), total hip BMD of the contralateral limb (− 1.4%, p = 0.005), femoral neck BMD of the ipsilateral limb (− 2.8%, p < 0.001) and femoral neck BMD of the contralateral limb (− 2.2%, p = 0.008) were observed after 12 weeks. Lumbar spine and forearm BMD were unchanged. HbA1c improved from 75 mmol/mol (9.2%) to 64 mmol/mol (8.0%) (p = 0.002). No significant changes to lean and fat mass were demonstrated. Total hip and femoral neck BMD decreased bilaterally 12 weeks after hospitalisation for DFU. Future research is required to confirm the persistence and clinical implications of these losses.

scholarly journals Bone mineral density and hip structural analysis in type 1 diabetic men

2007 ◽  
Vol 156 (1) ◽  
pp. 123-127 ◽  
Author(s):  
Tomasz Miazgowski ◽  
Slawomir Pynka ◽  
Marzena Noworyta-Ziętara ◽  
Barbara Krzyzanowska-Świniarska ◽  
Robert Pikul
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Metabolic Control ◽  
Bone Mineral ◽  
Microvascular Complications ◽  
Mineral Density ◽  
Hip Strength ◽  
Total Hip ◽  
Hip Bmd

Objective: The risk of non-vertebral fractures is increased in men with type 1 diabetes (DM1) but studies have shown only moderately decreased or normal bone mineral density (BMD) in these patients. No previous studies have evaluated hip strength and geometry indices in DM1 patients. This study was therefore designed to characterize associations between BMD, dual X-ray absorptiometry (DXA)-based hip strength indices, metabolic control, and DM1chronic complications. Design and methods: The study was performed on 36 males aged 43.6 ± 5.1 years with long-lasting DM1 and 36 healthy males matched for age, weight, and height. BMD in lumbar spine, total hip, upper and lower part of the femoral neck, hip axis length, cross-sectional area and moment of inertia (CSMI), and glycated hemoglobin (HbA1c) were measured. Results: DM1 men had decreased spine BMD (P < 0.05) and normal total hip BMD in comparison with controls. Hip geometry and strength indices were comparable in both groups. However, M1 men had decreased CSMI and upper femur BMD but these differences did not reach statistical significance (P = 0.06). BMD changes and hip strength parameters did not correlate with HbA1c. Conclusions: Middle-aged DM1 men have decreased lumbar spine BMD, normal hip BMD and normal hip strength indices. These changes are not influenced by metabolic control and presence of chronic microvascular complications.

scholarly journals Efficacy and Safety of Human Parathyroid Hormone-(1–84) in Increasing Bone Mineral Density in Postmenopausal Osteoporosis

2003 ◽  
Vol 88 (11) ◽  
pp. 5212-5220 ◽  
Author(s):  
Anthony B. Hodsman ◽  
David A. Hanley ◽  
Mark P. Ettinger ◽  
Michael A. Bolognese ◽  
John Fox ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Postmenopausal Osteoporosis ◽  
Bone Mineral ◽  
Full Length ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Mineral Density ◽  
Double Blind ◽  
Hip Bmd

Abstract Daily sc injections of N-terminal analogs of PTH increase bone mass and decrease fractures in osteoporotic women. We investigated the efficacy and safety of human PTH-(1–84) (full-length PTH) in the treatment of postmenopausal osteoporosis in a double-blind, placebo-controlled study. The women (n = 50–53/group) self-administered PTH (50, 75, or 100 μg) or placebo by daily sc injection for 12 months. PTH treatment induced time- and dose-related increases in lumbar spine bone mineral density (BMD). The 100-μg dose increased BMD significantly at 3 months (+2.0%) and 12 months (+7.8%). BMD underestimated the anabolic effect of PTH in lumbar spine (bone mineral content, +10.0%) because bone area increased significantly (+2.0%). A nonsignificant decrease (−0.9%) in total hip BMD occurred during the first 6 months with the 100-μg dose, but this trend reversed (+1.6%) during the second 6 months. Bone turnover markers increased during the first half of the study and were maintained at elevated levels during the second 6 months. Protocol compliance was excellent (95–98%), and treatment was generally safe and well tolerated. Dose-related incidences of transient hypercalcemia occurred, but only one patient (100-μg group) was withdrawn because of repeated hypercalcemia. Thus, full-length PTH was efficacious and safe over 12 months.

scholarly journals Musculoskeletal and prostate effects of combined testosterone and finasteride administration in older hypogonadal men: a randomized, controlled trial

2014 ◽  
Vol 306 (4) ◽  
pp. E433-E442 ◽  
Author(s):  
Stephen E. Borst ◽  
Joshua F. Yarrow ◽  
Christine F. Conover ◽  
Unyime Nseyo ◽  
John R. Meuleman ◽  
...  
Keyword(s):  
Muscle Strength ◽  
Body Fat ◽  
Controlled Trial ◽  
Serum Testosterone ◽  
Fat Free Mass ◽  
Mineral Density ◽  
Prostate Enlargement ◽  
Total Body Fat ◽  
Hip Bmd ◽  
Total Body

Testosterone acts directly at androgen receptors and also exerts potent actions following 5α-reduction to dihydrotestosterone (DHT). Finasteride (type II 5α-reductase inhibitor) lowers DHT and is used to treat benign prostatic hyperplasia. However, it is unknown whether elevated DHT mediates either beneficial musculoskeletal effects or prostate enlargement resulting from higher-than-replacement doses of testosterone. Our purpose was to determine whether administration of testosterone plus finasteride to older hypogonadal men could produce musculoskeletal benefits without prostate enlargement. Sixty men aged ≥60 yr with a serum testosterone concentration of ≤300 ng/dl or bioavailable testosterone ≤70 ng/dl received 52 wk of treatment with testosterone enanthate (TE; 125 mg/wk) vs. vehicle, paired with finasteride (5 mg/day) vs. placebo using a 2 × 2 factorial design. Over the course of 12 mo, TE increased upper and lower body muscle strength by 8–14% ( P = 0.015 to <0.001), fat-free mass 4.04 kg ( P = 0.032), lumbar spine bone mineral density (BMD) 4.19% ( P < 0.001), and total hip BMD 1.96% ( P = 0.024) while reducing total body fat −3.87 kg ( P < 0.001) and trunk fat −1.88 kg ( P = 0.0051). In the first 3 mo, testosterone increased hematocrit 4.13% ( P < 0.001). Coadministration of finasteride did not alter any of these effects. Over 12 mo, testosterone also increased prostate volume 11.4 cm3 ( P = 0.0051), an effect that was completely prevented by finasteride ( P = 0.0027). We conclude that a higher-than-replacement TE combined with finasteride significantly increases muscle strength and BMD and reduces body fat without causing prostate enlargement. These results demonstrate that elevated DHT mediates testosterone-induced prostate enlargement but is not required for benefits in musculoskeletal or adipose tissue.

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