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Study of Investigational Drug in Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092053
First received: September 21, 2004
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  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:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Merck:

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
Investigators
Study Director: Medical Monitor Merck
  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:
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 June 17, 2013