Pharmacotherapy of Bone Loss in Postmenopausal Women: Focus on Denosumab

2009 ◽  
Vol 1 ◽  
pp. CMT.S1089
Author(s):  
Alejandro Roman-Gonzalez ◽  
Kathryn E. Ackerman
Keyword(s):  
Postmenopausal Women ◽  
Opportunistic Infections ◽  
Human Monoclonal Antibody ◽  
Safety Information ◽  
Study Groups ◽  
Mineral Density ◽  
Phase 3 ◽  
Turnover Markers ◽  
Near Future

Denosumab is a human monoclonal antibody against RANKL. This antibody decreases bone turnover markers and increases bone mineral density (BMD) in postmenopausal women. In phase 3 studies including more than 1100 women, denosumab achieved greater increases in lumbar spine, total hip, distal 1/3 radius, and total BMD than alendronate 70 mg weekly. Recent data suggest that denosumab also decreases vertebral and non-vertebral fractures. This drug seems to be safe, although the most frequent side effects are arthralgia, back pain, and nasopharyngitis. No increased incidence of neoplasia has been found compared to placebo or alendronate. However, infections requiring inpatient treatment were more frequent in study groups treated with denosumab. These were common community acquired infections and were treated with standard antibiotics. No opportunistic infections were reported. Denosumab is a very promising new drug for the treatment of osteopenia and osteoporosis, and hopefully more long-term safety information and further fracture data will support its commercial use in the near future.

Efficacy of odanacatib in postmenopausal women with osteoporosis: subgroup analyses of data from the phase 3 long-term odanacatib fracture trial (LOFT)

2016 ◽  
Author(s):  
Kenneth G Saag ◽  
Peter Alexandersen ◽  
Claude-Laurent Benhamou ◽  
Nigel Gilchrist ◽  
Johan Halse ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Phase 3 ◽  
Subgroup Analyses

scholarly journals Effect of Denosumab on Bone Mineral Density and Markers of Bone Turnover among Postmenopausal Women with Osteoporosis

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
A. Sánchez ◽  
L. R. Brun ◽  
H. Salerni ◽  
P. R. Costanzo ◽  
D. González ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Bone Turnover ◽  
Postmenopausal Women ◽  
Bone Mineral ◽  
Bone Turnover Markers ◽  
Control Group ◽  
Bone Resorption Marker ◽  
Similar Response ◽  
Mineral Density ◽  
Turnover Markers

The aim of this study was to evaluate the effect of denosumab (Dmab) on bone mineral density (BMD) and bone turnover markers after 1 year of treatment. Additionally, the effect of Dmab in bisphosphonate-naïve patients (BP-naïve) compared to patients previously treated with bisphosphonates (BP-prior) was analyzed. This retrospective study included 425 postmenopausal women treated with Dmab for 1 year in clinical practice conditions in specialized centers from Argentina. Participants were also divided according to previous bisphosphonate treatment into BP-naïve and BP-prior. A control group of patients treated with BP not switched to Dmab matched by sex, age, and body mass index was used. Data are expressed as mean ± SEM. After 1 year of treatment with Dmab the bone formation markers total alkaline phosphatase and osteocalcin were significantly decreased (23.36% and 43.97%, resp.), as was the bone resorption marker s-CTX (69.61%). Significant increases in BMD were observed at the lumbar spine, femoral neck, and total hip without differences between BP-naïve and BP-prior. A better BMD response was found in BP-prior group compared with BP treated patients not switched to Dmab.Conclusion. Dmab treatment increased BMD and decreased bone turnover markers in the whole group, with similar response in BP-naïve and BP-prior patients. A better BMD response in BP-prior patients versus BP treated patients not switched to Dmab was observed.

Circulating Biomarkers Related to Osteocyte and Calcium Homeostasis between Postmenopausal Women with and without Osteoporosis

2021 ◽  
Vol 21 ◽  
Author(s):  
Chin Yi Chan ◽  
Shaanthana Subramaniam ◽  
Norazlina Mohamed ◽  
Norliza Muhammad ◽  
Fitri Fareez Ramli ◽  
...  
Keyword(s):  
Bone Turnover ◽  
Postmenopausal Women ◽  
Calcium Homeostasis ◽  
Bone Cells ◽  
Control Group ◽  
Protein Markers ◽  
Mineral Density ◽  
Hydroxyvitamin D ◽  
Hip Bmd ◽  
Turnover Markers

Background: The currently available bone turnover markers are mostly derived from osteoblasts or osteoclasts. Protein markers derived from osteocytes, the most abundant bone cells that can regulate bone turnover activities by other cells, are less explored. Objective: This study aimed to compare the circulating markers of osteocytes and calcium homeostasis between Malaysian postmenopausal women with and without osteoporosis. Method: Postmenopausal women with (n=20) or without osteoporosis (n=20) as determined by dual-energy X-ray absorptiometry were randomly drawn from a bone health cohort. Their fasting blood was collected and assayed by a multiplex immunoassay panel. Results: The results showed that osteoprotegerin and sclerostin levels were significantly lower among postmenopausal women with osteoporosis than the normal control. No significant differences in other markers were observed between the two groups. Sclerostin level correlated positively with spine bone mineral density (BMD), while 25-hydroxyvitamin D correlated negatively with hip BMD in the control group. No significant correlation was observed between other markers with spine or hip BMD. Conclusion: These data provide an insight into the possible roles of osteocyte markers, especially osteoprotegerin and sclerostin in classifying subjects with osteoporosis. However, the lack of association between these markers and BMD indicates that osteoporosis is a complex and multifactorial condition.

scholarly journals Effects of denosumab in Japanese rheumatoid arthritis patients treated with conventional anti-rheumatic drugs: 36-month extension of a phase 3 study

2021 ◽  
pp. jrheum.201376
Author(s):  
Yoshiya Tanaka ◽  
Tsutomu Takeuchi ◽  
Satoshi Soen ◽  
Hisashi Yamanaka ◽  
Toshiyuki Yoneda ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Type I Collagen ◽  
Joint Destruction ◽  
Term Treatment ◽  
Drug Discontinuation ◽  
Type I ◽  
Mineral Density ◽  
Phase 3 ◽  
Long Term Treatment

Objective To evaluate safety and efficacy of long-term denosumab 60 mg every 6 (Q6M) or 3 months (Q3M) in rheumatoid arthritis (RA) patients. Methods This 12-month, randomised, double-blind, placebo-controlled, multicentre phase 3 trial with an open-label extension period from 12 to 36 months (DESIRABLE) enrolled Japanese RA patients treated with placebo for 12 months then denosumab Q6M (P/Q6M) or denosumab Q3M (P/Q3M); denosumab Q6M for 36 months (Q6M/Q6M); or denosumab Q3M for 36 months (Q3M/Q3M). Efficacy was assessed by van der Heijde modified total Sharp (mTSS), bone erosion (ES), and joint space narrowing (JSN) scores. Results Long-term treatment better maintained mTSS and ES suppression in the P/Q3M and Q3M/Q3M versus P/Q6M and Q6M/Q6M groups; changes from baseline in total mTSS at 36 months were 2.8 (standard error 0.4), 1.7 (0.3), 3.0 (0.4), and 2.4 (0.3), respectively; corresponding changes in ES were 1.3 (0.2), 0.4 (0.2), 1.4 (0.2), and 1.1 (0.2). No JSN effect was observed. Bone mineral density consistently increased in all groups after denosumab initiation, regardless of concomitant glucocorticoid administration. Serum C-telopeptide of type I collagen decreased rapidly at 1-month post-denosumab administration (both in the initial 12- month [Q3M, Q6M groups] and long-term treatment [P/Q3M, P/Q6M groups] phases). Adverse event incidence leading to study drug discontinuation was similar across treatment groups. Conclusion Denosumab treatment maintained inhibition of progression of joint destruction up to 36 months. Based on effects on ES progression, higher dosing frequency at an earlier treatment stage may be needed to optimise treatment. Denosumab was generally well tolerated.

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