Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Investigational Drug in Osteoporosis
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00092053
  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: MK-0217, alendronate sodium/Duration of Treatment: 3 months
Drug: Comparator: placebo / Duration of Treatment: 3 months
Phase III

MedlinePlus related topics: Osteoporosis
Drug Information available for: Alendronate Alendronate sodium Ibandronate sodium Ibandronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Safety/Efficacy Study
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

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 Unaffiliated
  More Information

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2004_007, MK0217-908
Study First Received: September 21, 2004
Last Updated: September 26, 2008
ClinicalTrials.gov Identifier: NCT00092053  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck:
Postmenopausal
Osteoporosis

Study placed in the following topic categories:
Ibandronic acid
Musculoskeletal Diseases
Alendronate
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009