scholarly journals Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study

2018 ◽  
Vol 37 (6) ◽  
pp. 1862-1870 ◽  
Author(s):  
Lee-Jane W. Lu ◽  
Nai-Wei Chen ◽  
Fatima Nayeem ◽  
V-M. Sadagopa Ramanujam ◽  
Yong-Fang Kuo ◽  
...  
Keyword(s):  
Serum Calcium ◽  
Premenopausal Women ◽  
Soy Isoflavones ◽  
Controlled Study ◽  
Double Blind

A simple enzyme-linked immunosorbent assay of human osteocalcin

1994 ◽  
Vol 40 (7) ◽  
pp. 1258-1264 ◽  
Author(s):  
C Rosenquist ◽  
M Bonde ◽  
C Fledelius ◽  
P Qvist
Keyword(s):  
Postmenopausal Women ◽  
Polyclonal Antibodies ◽  
Premenopausal Women ◽  
Controlled Study ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Osteocalcin ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Early Postmenopausal Women ◽  
Log Linear

Abstract A heterologous ELISA for measurement of osteocalcin (bone Gla-protein) is described, involving biotinylated bovine osteocalcin and polyclonal antibodies. The log-linear range was 2.3-37.5 micrograms/L. Between-run (total) and within-run CVs (n = 10) were 5.7-6.4 and 5.9-6.1%, respectively; analytical recoveries ranged from 92% to 108%. Comparison of our method (x) with an RIA (y) yielded y = 1.10 x -0.01 microgram/L, Sylx = 1.4 micrograms/L, r = 0.958 (n = 167). Serum osteocalcin in healthy premenopausal women (n = 29) was 8.7 +/- 3.3 micrograms/L (mean +/- SD) and 11.8 +/- 4.5 micrograms/L in early-postmenopausal women (n = 24). The assay was evaluated in a double-blind placebo-controlled study of healthy early-postmenopausal women, treated for 12 months with either (a) estrogen valerate plus medroxyprogesterone acetate (n = 18), (b) 17 beta-estradiol and desogestrel (n = 22), or (c) placebo (n = 17). Serum osteocalcin decreased significantly (P < 0.001) with either therapy, but increased (P < 0.05) with placebo.

scholarly journals A placebo-controlled study of three osteocalcin assays for assessment of prednisolone-induced suppression of bone turnover

1998 ◽  
Vol 159 (1) ◽  
pp. 127-131 ◽  
Author(s):  
C Heuck ◽  
OD Wolthers
Keyword(s):  
Bone Turnover ◽  
Premenopausal Women ◽  
Controlled Study ◽  
Serum Osteocalcin ◽  
Double Blind ◽  
Prednisolone Treatment ◽  
Parallel Group ◽  
The Individual ◽  
Oral Glucocorticoids ◽  
Sensitive Marker

Serum osteocalcin is a sensitive marker of suppressive effects of exogenous glucocorticoids on bone turnover. It has been suggested, however, that the degree of suppression detected by different assays may vary. Whether discrepancies between various assays influence conclusions from group studies of exogenous glucocorticoids has not been evaluated. The aim of the present study was to compare the CAP fluoroimmunoassay (FEIA), OSTK-PR and ELSA-OSTEO assays for assessment of prednisolone-induced effects on serum osteocalcin. Twelve men and eight premenopausal women aged 19-45 (mean 31) years were studied. All subjects were healthy. The design was a randomised double-blind, placebo-controlled parallel- group study with 2 days run-in, 3 days treatment and 4 days run-out. During run-in and run-out no medication was given. During the treatment period the subjects took either 20 mg prednisolone twice daily or placebo. Blood was collected on the last day of each period. Intra- and intergroup comparisons showed prednisolone treatment to be associated with a statistically significant suppression of osteocalcin which was detected by all assays (ANOVA;P<0.0001). In the individual subjects the response to prednisolone was the same for each assay. The CAP FEIA, OSTK-PR and ELSA-OSTEO assays seem equally sensitive for evaluation of osteocalcin in group studies of oral glucocorticoids.

scholarly journals Almotriptan 12.5 mg in menstrually related migraine: A randomized, double-blind, placebo-controlled study

Cephalalgia ◽  
2010 ◽  
Vol 31 (2) ◽  
pp. 144-151 ◽  
Author(s):  
Gianni Allais ◽  
Gennaro Bussone ◽  
Giovanni D’Andrea ◽  
Franca Moschiano ◽  
Florindo d’Onofrio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rescue Medication ◽  
Premenopausal Women ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Prospective Data ◽  
Menstrually Related Migraine ◽  
Suitable Target

Background: Menstrually related migraine (MRM) affects more than half of female migraineurs. Because such migraines are often predictable, they provide a suitable target for treatment in the mild pain phase. The present study was designed to provide prospective data on the efficacy of almotriptan for treatment of MRM. Methods: Premenopausal women with MRM were randomized to almotriptan ( N = 74) or placebo ( N = 73), taken at onset of the first perimenstrual migraine. Patients crossed over to the other treatment for the first perimenstrual migraine of their second cycle, followed by a two-month open-label almotriptan treatment period. Results: Significantly more patients were pain-free at two hours (risk ratio [RR] = 1.81; p = .0008), pain-free from 2–24 hours with no rescue medication (RR = 1.99; p = .0022), and pain-free from 2–24 hours with no rescue medication or adverse events (RR = 1.94; p = .0061) with almotriptan versus placebo. Nausea ( p = .0007) and photophobia ( p = .0083) at two hours were significantly less frequent with almotriptan. Almotriptan efficacy was consistent between three attacks, with 56.2% of patients pain-free at two hours at least twice. Adverse events were similar with almotriptan and placebo. Conclusion: Almotriptan was significantly more effective than placebo in women with MRM attacks, with consistent efficacy in longer-term follow-up.

scholarly journals Effects of GH in women with abdominal adiposity: a 6-month randomized, double-blind, placebo-controlled trial

2012 ◽  
Vol 166 (4) ◽  
pp. 601-611 ◽  
Author(s):  
Miriam A Bredella ◽  
Eleanor Lin ◽  
Danielle J Brick ◽  
Anu V Gerweck ◽  
Lindsey M Harrington ◽  
...  
Keyword(s):  
Body Composition ◽  
Adipose Tissue ◽  
Cardiovascular Risk ◽  
Premenopausal Women ◽  
Thigh Muscle ◽  
Controlled Study ◽  
Abdominal Adiposity ◽  
Risk Markers ◽  
Double Blind ◽  
Double Blind Placebo

ObjectiveAbdominal adiposity is associated with increased cardiovascular risk and decreased GH secretion. The objective of our study was to determine the effects of GH on body composition and cardiovascular risk markers in abdominally obese women.Materials and methodsIn this randomized, double-blind, placebo-controlled study, 79 obese premenopausal women received GH vs placebo for 6 months. Primary endpoints were i) total abdominal (total abdominal adipose tissue, TAT) fat by computed tomography (CT) (body composition) and ii) high-sensitivity C-reactive protein (hsCRP) (cardiovascular risk marker). Body composition was assessed by CT, dual-energy X-ray absorptiometry, and proton MR spectroscopy. Serum cardiovascular risk markers, carotid intima-media thickness, and endothelial function were measured.ResultsMean 6-month GH dose was 1.7±0.1 mg/day, resulting in a mean IGF1 SDS increase from −1.7±0.08 to −0.1±0.3 in the GH group. GH administration decreased TAT and hsCRP compared with placebo. In addition, it increased thigh muscle mass and lean body mass and decreased subcutaneous abdominal and trunk fat, tissue plasminogen activator, apoB, and apoB/low-density lipoprotein compared with placebo. Visceral adipose tissue (VAT) decreased and intramyocellular lipid increased within the GH group. Six-month change in IGF1 levels was negatively associated with 6-month decrease in TAT and VAT. One subject had a 2 h glucose >200 mg/ml at 3 months; four subjects, three of whom were randomized to GH, had 2 h glucose levels >200 mg/ml at the end of the study.ConclusionGH administration in abdominally obese premenopausal women exerts beneficial effects on body composition and cardiovascular risk markers but is associated with a decrease in glucose tolerance in a minority of women.

scholarly journals Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery

2015 ◽  
Vol 172 (5) ◽  
pp. 527-535 ◽  
Author(s):  
Aliya Khan ◽  
John Bilezikian ◽  
Henry Bone ◽  
Andrey Gurevich ◽  
Peter Lakatos ◽  
...  
Keyword(s):  
Primary Hyperparathyroidism ◽  
Serum Calcium ◽  
Controlled Study ◽  
Total Serum ◽  
Open Label ◽  
Double Blind ◽  
Serum Calcium Concentration ◽  
Total Serum Calcium ◽  
Normal Mean ◽  
Serum Pth

ObjectivePrimary hyperparathyroidism (PHPT) is diagnosed by the presence of hypercalcemia and elevated or nonsuppressed parathyroid hormone (PTH) levels. Although surgery is usually curative, some individuals fail or are unable or unwilling to undergo parathyroidectomy. In such individuals, targeted medical therapy may be of value. Cinacalcet normalized calcium level and lowered PTH in patients with PHPT in several phase 2 and open-label studies. We compared cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy.DesignPhase 3, double-blind, multi centere, randomized, placebo-controlled study.MethodsSixty-seven subjects (78% women) with moderate PHPT were randomized (1:1) to cinacalcet or placebo for ≤28 weeks.Main outcome measureAchievement of a normal mean corrected total serum calcium concentration of ≤10.3 mg/dl (2.575 mmol/l).ResultsBaseline median (quartile 1 (Q1), Q3) serum PTH was 164.0 (131.0, 211.0) pg/ml and mean (s.d.) serum Ca was 11.77 (0.46) mg/dl. Serum Ca normalized (≤10.3 mg/dl) in 75.8% of cinacalcet- vs 0% of placebo-treated subjects (P<0.001). Corrected serum Ca decreased by ≥1.0 mg/dl from baseline in 84.8% of cinacalcet- vs 5.9% of placebo-treated subjects (P<0.001). Least squares mean (s.e.m.) plasma PTH change from baseline was −23.80% (4.18%) (cinacalcet) vs −1.01% (4.05%) (placebo) (P<0.001). Similar numbers of subjects in the cinacalcet and placebo groups reported adverse events (AEs) (27 vs 20) and serious AEs (three vs four). Most commonly reported AEs were nausea and muscle spasms.ConclusionsThese results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated.

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