Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial

Recker, Robert; Lips, Paul; Felsenberg, Dieter; Lippuner, Kurt; Benhamou, Laurent; Hawkins, Federico; Delmas, Pierre D; Rosen, Clifford; Emkey, Ronald; Salzmann, Gretel; He, Weili; Santora, Arthur C (2006). Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Current medical research and opinion, 22(9), pp. 1745-55. London: Informa Healthcare 10.1185/030079906X120913

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OBJECTIVE: Many osteoporosis patients have low 25-hydroxyvitamin D (25OHD) and do not take recommended vitamin D amounts. A single tablet containing both cholecalciferol (vitamin D3) and alendronate would improve vitamin D status concurrently, with a drug shown to reduce fracture risk. This study assessed the efficacy, safety, and tolerability of a once-weekly tablet containing alendronate 70 mg and cholecalciferol 70 microg (2800 IU) (ALN + D) versus alendronate 70 mg alone (ALN). METHODS: This 15-week, randomized, double-blind, multi-center, active-controlled study was conducted during a season when 25OHD levels are declining, and patients were required to avoid sunlight and vitamin D supplements for the duration of the study. Men (n = 35) and postmenopausal women (n = 682) with osteoporosis and 25OHD >or= 9 ng/mL were randomized to ALN + D (n = 360) or ALN (n = 357). MAIN OUTCOME MEASURES: Serum 25OHD, parathyroid hormone, bone-specific alkaline phosphatase (BSAP), and urinary N-telopeptide collagen cross-links (NTX). RESULTS: Serum 25OHD declined from 22.2 to 18.6 ng/mL with ALN (adjusted mean change = -3.4; 95% confidence interval [CI]: -4.0 to -2.8), and increased from 22.1 to 23.1 ng/mL with ALN + D (adjusted mean change = 1.2; 95% CI: 0.6 to 1.8). At 15 weeks, adjusted mean 25OHD was 26% higher (p < 0.001, ALN + D versus ALN), the adjusted relative risk (RR) of 25OHD < 15 ng/mL (primary endpoint) was reduced by 64% (incidence 11% vs. 32%; RR = 0.36; 95% CI: 0.27 to 0.48 [p < 0.001]), and the RR of 25OHD < 9 ng/mL (a secondary endpoint) was reduced by 91% (1% vs. 13%; RR = 0.09; 95% CI: 0.03 to 0.23 [p < 0.001]). Antiresorptive efficacy was unaltered, as measured by reduction in bone turnover (BSAP and NTX). CONCLUSION: In osteoporosis patients who avoided sunlight and vitamin D supplements, this once-weekly tablet containing alendronate and cholecalciferol provided equivalent antiresorptive efficacy, reduced the risk of low serum 25OHD, improved vitamin D status over 15 weeks, and was not associated with hypercalcemia, hypercalciuria or other adverse findings, versus alendronate alone.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Orthopaedic, Plastic and Hand Surgery (DOPH) > Clinic of Osteoporosis
UniBE Contributor:	Lippuner, Kurt
ISSN:	0300-7995
ISBN:	16968578
Publisher:	Informa Healthcare
Language:	English
Submitter:	Factscience Import
Date Deposited:	04 Oct 2013 14:51
Last Modified:	05 Dec 2022 14:15
Publisher DOI:	10.1185/030079906X120913
PubMed ID:	16968578
Web of Science ID:	000241152700016
URI:	https://boris.unibe.ch/id/eprint/21578 (FactScience: 7965)