Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00729651
First received: August 5, 2008
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

To demonstrate the efficacy/safety of Fosamax Plus D


Condition Intervention Phase
Osteoporosis Postmenopausal
Drug: alendronate sodium (+) cholecalciferol
Drug: Comparator: Alendronate sodium (Fosamax)
Dietary Supplement: Comparator: Calcium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Alendronate sodium/Cholecalciferol
Drug: alendronate sodium (+) cholecalciferol
Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
Other Name: Fosamax Plus D
Dietary Supplement: Comparator: Calcium
500 mg oral tablet calcium once daily, for 16 weeks
Active Comparator: 2
Alendronate sodium
Drug: Comparator: Alendronate sodium (Fosamax)
Alendronate sodium; tablet, once weekly, for 16 weeks
Dietary Supplement: Comparator: Calcium
500 mg oral tablet calcium once daily, for 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
  • Patient has been diagnosed with osteoporosis
  • Patient has been postmenopausal for more than 6 months
  • Patient has no contraindication to taking oral bisphosphonates
  • Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion Criteria:

  • Patients with esophageal dysfunction
  • Patients who can not sit or stand at least 30 minutes
  • Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
  • Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
  • Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
  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: NCT00729651

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: NCT00729651     History of Changes
Other Study ID Numbers: 0217A-263, MK0217A-263, 2008_015
Study First Received: August 5, 2008
Results First Received: February 5, 2010
Last Updated: August 11, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014