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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092014
First received: September 21, 2004
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Alendronate
Drug: Risedronate 35 mg
Dietary Supplement: Elemental Calcium
Dietary Supplement: Vitamin D
Drug: Risendronate placebo
Drug: Alendronate placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean percent change from baseline in hip trochanter BMD at 24 months [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in biochemical markers of bone turnover at 12 months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in biochemical markers of bone turnover at 24 months [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of participants who experienced one or more adverse events (AE) [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study medication due to an AE [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 1053
Study Start Date: September 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate 70 mg
Alendronate sodium, 70 mg, orally once weekly for up to 24 months
Drug: Alendronate
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®
Dietary Supplement: Elemental Calcium
Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
Dietary Supplement: Vitamin D
Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
Drug: Risendronate placebo
Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
Active Comparator: Risendronate 35 mg
Risendronate, 35 mg, orally once weekly for up to 24 months
Drug: Risedronate 35 mg
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®
Dietary Supplement: Elemental Calcium
Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
Dietary Supplement: Vitamin D
Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
Drug: Alendronate placebo
Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092014

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092014     History of Changes
Other Study ID Numbers: 0217-211, 2004_016
Study First Received: September 21, 2004
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Vitamins
Risedronic acid
Alendronate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014