Study of Investigational Drug in Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092053
First received: September 21, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: MK0217, alendronate sodium/Duration of Treatment: 3 months
Drug: Comparator: placebo / Duration of Treatment: 3 months
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Investigator)
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Biochemical markers of bone reception (CTxI and NTx/Cr)

Secondary Outcome Measures:
  • Safety and tolerability

Estimated Enrollment: 180
Study Start Date: January 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with osteoporosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092053

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092053     History of Changes
Other Study ID Numbers: 2004_007, MK0217-908
Study First Received: September 21, 2004
Last Updated: January 21, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck Sharp & Dohme Corp.:
Postmenopausal
Osteoporosis

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 16, 2014