Authors: Recker, Robert¹; Lips, Paul²; Felsenberg, Dieter³; Lippuner, Kurt⁴; Benhamou, Laurent⁵; Hawkins, Federico⁶; Delmas, Pierre D.⁷; Rosen, Clifford⁸; Emkey, Ronald⁹; Salzmann, Gretel¹⁰; He, Weili¹⁰; Santora, Arthur C.¹⁰

Source: Current Medical Research and Opinion, Volume 22, Number 9, September 2006 , pp. 1745-1755(11)

Publisher: Informa Healthcare

Abstract:

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 70mg and cholecalciferol 70μg (2800IU) (ALN + D) versus alendronate 70mg alone (ALN).

Methods: This 15-week, randomized, doubleblind, 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 ≥ 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 18.6ng/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.

Keywords: ALENDRONATE; CHOLECALCIFEROL; OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; SERUM 25-HYDROXYVITAMIN D; VITAMIN D

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079906X120913

Affiliations: 1: Creighton University, Osteoporosis Research Center, Omaha, NE, USA 2: Vrije Universiteit Medical Center, Amsterdam, The Netherlands 3: University Hospital Benjamin Franklin, Berlin, Germany 4: University Hospital of Berne, Berne, Switzerland 5: Centre Hospitalier Regional, Orleans 45032, France 6: Hospital Universitario 12 de Octubre, Madrid 28041, Spain 7: University Claude Bernard of Lyon, Lyon, France 8: St. Joseph Hospital, Bangor, ME, USA 9: Radiant Research, Reading, PA, USA 10: Merck Research Laboratories, Rahway, NJ, USA

Publication date: 2006-09-01

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