A Study to Evaluate the Safety and Tolerability of MK0217 in Women

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092027
First received: September 21, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: MK0217, alendronate sodium/Duration of Treatment: 6 months
Drug: Comparator: placebo / Duration of Treatment: 6 months
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 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis

Secondary Outcome Measures:
  • To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
  • To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months

Enrollment: 454
Study Start Date: March 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  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:

  • High risk for fractures
  • Esophageal abnormalities
  • Upper gastrointestinal symptoms that are not relieved with medication
  • Metabolic bone disease (example - vitamin D deficiency)
  • Medications that would affect the breakdown or build-up of bone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092027

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092027     History of Changes
Other Study ID Numbers: 2004_017, MK0217-219
Study First Received: September 21, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014