A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092027
First received: September 21, 2004
Last updated: May 2, 2014
Last verified: May 2014
  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
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: NCT00092027

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: NCT00092027     History of Changes
Other Study ID Numbers: 0217-219, MK0217-219, 2004_017
Study First Received: September 21, 2004
Last Updated: May 2, 2014
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 August 21, 2014