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Weekly Oral Alendronic Acid in Male Osteoporosis

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Abstract

Objective: To evaluate the efficacy and tolerability of alendronic acid 70mg once weekly for the treatment of male osteoporosis.

Patients and methods: This randomised, double-blind, placebo-controlled, 12-month trial compared the effect of alendronic acid 70mg once weekly or placebo (randomised 2: 1) on bone mineral density (BMD) in 167 men with spine or hip BMD at least 2 standard deviations (SD) below the mean for young normal white males or nontraumatic fracture. All patients received calcium and vitamin D (colecalciferol). We measured lumbar spine, hip and total body BMD, and biochemical markers of bone turnover. Fractures were collected as adverse events.

Results: Alendronic acid 70mg once weekly produced significant BMD increases from baseline of 4.3% at the spine, 2.1% at the femoral neck, 2.4% at the trochanter, and 1.4% at the total body, which were all significantly greater than placebo (p < 0.05). The increase at the lumbar spine was significant relative to baseline and placebo after 6 months of treatment (p < 0.001). The treatment effect was consistent regardless of BMD, age, height, weight, body mass index (BMI) and hypogonadal status at baseline. Alendronic acid significantly decreased biochemical markers of bone turnover relative to baseline and placebo. Alendronic acid was generally well tolerated, with an incidence of gastrointestinal adverse events similar to placebo.

Conclusion: Alendronic acid 70mg administered once weekly is an effective and convenient alternative to daily dosing for the treatment of male osteoporosis.

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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The authors wish to thank Philip D. Ross, PhD and Christine Sisk for their assistance in preparing this manuscript.

Funding for this clinical trial was provided by Merck Research Laboratories, Rahway, NJ, USA.

Presented in part at the 2nd International Conference on Osteoporosis in Men, 2–6 April 2003, Genoa, Italy.

K. Vandormael and A. Daifotis are employees of Merck & Co., Inc., and potentially own stock and/or hold stock options in the Company.

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Authors and Affiliations

  1. Colorado Center for Bone Research, 3190, S. Wadsworth, Suite 250, Lakewood, Colorado, 80227, USA

    Paul D. Miller

  2. Northwestern University, Chicago, Illinois, USA

    Thomas Schnitzer

  3. Emkey Arthritis & Osteoporosis Clinic and Radiant Research, Wyomissing, Pennsylvania, USA

    Ronald Emkey

  4. Oregon Health Sciences University, Portland, Oregon, USA

    Eric Orwoll

  5. Maine Center for Osteoporosis Research, St Joseph Hospital, Bangor, Maine, USA

    Clifford Rosen

  6. The Regional Osteoporosis Center of South Florida and Radiant Research, Stuart, Florida, USA

    Mark Ettinger

  7. Merck Research Laboratories, Brussels, Belgium

    Kristel Vandormael

  8. Merck Research Laboratories, Rahway, New Jersey, USA

    Anastasia Daifotis

Authors
  1. Paul D. Miller
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  2. Thomas Schnitzer
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  3. Ronald Emkey
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  4. Eric Orwoll
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  5. Clifford Rosen
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  6. Mark Ettinger
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  7. Kristel Vandormael
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  8. Anastasia Daifotis
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Corresponding author

Correspondence to Paul D. Miller.

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Miller, P.D., Schnitzer, T., Emkey, R. et al. Weekly Oral Alendronic Acid in Male Osteoporosis. Clin. Drug Investig. 24, 333–341 (2004). https://doi.org/10.2165/00044011-200424060-00003

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