Once-Weekly Oral Alendronate 70 mg in Patients with Glucocorticoid-Induced Bone Loss: A 12-Month Randomized, Placebo-Controlled Clinical Trial
ABSTRACT Glucocorticoid-induced osteoporosis is the most common iatrogenic form of osteoporosis. We evaluated the efficacy and safety of once-weekly bisphosphonate therapy for prevention and treatment of bone loss in patients on glucocorticoid therapy.
We conducted a 12-month, multicenter, randomized, double-blind, placebo-controlled trial with 114 and 59 patients in the treatment and placebo arms, respectively. Participants were stratified according to the duration of prior oral glucocorticoid therapy at randomization. Participants received alendronate 70 mg once weekly (ALN OW) or placebo; all received supplemental daily calcium (1000 mg) and 400 IU vitamin D. Clinical evaluations were performed at baseline, 3, 6, 9, and 12 months.
At 12 months, there was a significant mean percentage increase from baseline in the ALN OW group for lumbar spine (2.45%), trochanter (1.27%), total hip (0.75%), and total body (1.70%) bone mineral density (BMD). Comparing ALN OW versus placebo at 12 months, a significant treatment difference for the mean percentage change from baseline was observed for lumbar spine (treatment difference of 2.92%; p </= 0.001), trochanter (treatment difference 1.66%; p = 0.007), and total hip (treatment difference 1.19; p = 0.008) BMD. Biochemical markers of bone remodeling also showed significant mean percentage decreases from baseline.
Over 12 months ALN OW significantly increased lumbar spine, trochanter, total hip, and total body BMD compared with baseline among patients taking glucocorticoid therapy. A significant treatment difference versus placebo was observed at 12 months for the mean percentage change from baseline for lumbar spine, trochanter, and total hip.
Osteoporosis International 05/2014; 25(8). DOI:10.1007/s00198-014-2713-6 · 4.17 Impact Factor
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ABSTRACT: Beta-ecdysone (βEcd) is a phytoecdysteroid found in the dry roots and seeds of the asteraceae and achyranthes plants, and is reported to increase osteogenesis in vitro. Since glucocorticoid (GCs) excess is associated with a decrease in bone formation, the purpose of this study was to determine if treatment with βEcd could prevent GC-induced osteoporosis. Two-month-old male Swiss-Webster mice (n=8-10/group) were randomized to either placebo or slow release prednisolone pellets (3.3mg/kg/d) and treated with vehicle control or βEcd (0.5mg/kg/d) for 21days. GC treatment inhibited age-dependent trabecular gain and cortical bone expansion and this was accompanied by a 30-50% lower bone formation rate (BFR) at both the endosteal and periosteal surfaces. Mice treated with only βEcd significantly increased bone formation on endosteal and periosteal bone surfaces, and increased cortical bone mass were their controls to compare to GC alone. Concurrent treatment of βEcd and GC completely prevented the GC-induced reduction in BFR, trabecular bone volume and partially prevented cortical bone loss. In vitro studies determined that βEcd prevented the GC increase in autophagy of the bone marrow stromal cells as well as in whole bone. In summary, βEcd prevented GC induced changes in bone formation, bone cell viability and bone mass. Additional studies are warranted of βEcd for the treatment of GC induced bone loss. Copyright © 2015 Elsevier Inc. All rights reserved.Bone 01/2015; 74. DOI:10.1016/j.bone.2015.01.001 · 4.46 Impact Factor
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ABSTRACT: Purpose Both HIV infection and antiretroviral therapy (ART) are associated with significant decreases in bone mineral density (BMD) and increased fracture rates. To prepare for a randomized controlled trial of prophylactic bone antiresorptive therapy during ART initiation, we assessed the acceptability of this strategy, bone health knowledge, and fracture risk among HIV-infected adults. Methods HIV-infected adults with no history of osteoporosis were recruited from one tertiary and one primary care HIV clinic. Participants completed a questionnaire and underwent chart review. The primary outcome was the proportion of respondents expressing interest in taking prophylactic bone antiresorptive therapy in conjunction with ART. Results Of 112 respondents, 25.0% were ART naïve, 23.2% had been taking ART for ≤1 year, and 51.8% had been taking ART for >1 year. Half (51.9%) indicated interest in taking short-course prophylactic bone antiresorptive therapy; this did not differ by ART status (53.6% among ART-naïve, 51.3% among ART-treated; P=0.84, chi-square test). In exploratory multivariable analysis adjusted for ART status, a greater number of pills taken per day was positively associated with this outcome (adjusted odds ratio [OR] =1.12 per pill, 95% confidence limit [CL] =1.01, 1.25), while male sex was inversely associated (adjusted OR =0.05, 95% CL =0.01, 0.24). Among those willing to take therapy, most (80.4%) were willing to do so for “as long as needed” and preferred weekly dosing (70.9%) to daily dosing (12.7%). Conclusions Half of this sample would be willing to take bone antiresorptive therapy together with ART, with preferences for weekly dosing and for whatever duration may be required. These data will inform the design of future trials to protect bone health in HIV.Patient Preference and Adherence 09/2014; 8:1311-6. DOI:10.2147/PPA.S67090 · 1.49 Impact Factor