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Completed

NCT Number: NCT00092014

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with postmenopausal osteoporosis

Exclusion criteria

  • Bilateral hip replacements
  • Esophageal abnormalities
  • Metabolic bone disease (example - Vitamin D deficiency)
  • Medications that would affect the breakdown or build-up of bone turnover

Treatment and study plan

Alendronate

Drug

Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Other names: MK-0217, FOSAMAX®

Risedronate 35 mg

Drug

Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Other names: Actonel®, Atelvia®

Elemental Calcium

Dietary Supplement

Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

Vitamin D

Dietary Supplement

Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

Risendronate placebo

Drug

Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Alendronate placebo

Drug

Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Primary outcomes

  1. Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months

    Time frame: Baseline and 12 months

  2. Mean percent change from baseline in hip trochanter BMD at 24 months

    Time frame: Baseline and 24 months

Secondary outcomes

  1. Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months

    Time frame: Baseline and 12 months

  2. Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months

    Time frame: Baseline and 24 months

  3. Change from baseline in biochemical markers of bone turnover at 12 months

    Time frame: Baseline and 12 months

  4. Change from baseline in biochemical markers of bone turnover at 24 months

    Time frame: Baseline and 24 months

  5. Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months

    Time frame: 12 months

  6. Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months

    Time frame: 24 months

  7. Number of participants who experienced one or more adverse events (AE)

    Time frame: Up to 24 months

  8. Number of participants who discontinued study medication due to an AE

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

Acronym: FACT

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Sep 24, 2004
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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