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Trial record 79 of 105 for:    Risedronate

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

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ClinicalTrials.gov Identifier: NCT00092014
Recruitment Status : Completed
First Posted : September 24, 2004
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 21, 2004
First Posted Date  ICMJE September 24, 2004
Last Update Posted Date March 29, 2017
Actual Study Start Date  ICMJE September 1, 2002
Actual Primary Completion Date April 1, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months [ Time Frame: Baseline and 12 months ]
  • Mean percent change from baseline in hip trochanter BMD at 24 months [ Time Frame: Baseline and 24 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00092014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2013)
  • Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months [ Time Frame: Baseline and 12 months ]
  • Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months [ Time Frame: Baseline and 24 months ]
  • Change from baseline in biochemical markers of bone turnover at 12 months [ Time Frame: Baseline and 12 months ]
  • Change from baseline in biochemical markers of bone turnover at 24 months [ Time Frame: Baseline and 24 months ]
  • Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months [ Time Frame: 12 months ]
  • Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months [ Time Frame: 24 months ]
  • Number of participants who experienced one or more adverse events (AE) [ Time Frame: Up to 24 months ]
  • Number of participants who discontinued study medication due to an AE [ Time Frame: Up to 24 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • 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®
  • 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: Risendronate placebo
    Risendronate placebo was taken once weekly for up to 24 months. 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.
Study Arms  ICMJE
  • Experimental: Alendronate 70 mg
    Alendronate sodium, 70 mg, orally once weekly for up to 24 months
    Interventions:
    • Drug: Alendronate
    • Dietary Supplement: Elemental Calcium
    • Dietary Supplement: Vitamin D
    • Drug: Risendronate placebo
  • Active Comparator: Risendronate 35 mg
    Risendronate, 35 mg, orally once weekly for up to 24 months
    Interventions:
    • Drug: Risedronate 35 mg
    • Dietary Supplement: Elemental Calcium
    • Dietary Supplement: Vitamin D
    • Drug: Alendronate placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2013)
1053
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 1, 2004
Actual Primary Completion Date April 1, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00092014
Other Study ID Numbers  ICMJE 0217-211
2004_016 ( Other Identifier: Protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP