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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: August 5, 2008
Last updated: November 12, 2013
Last verified: November 2013

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


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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729651

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

No publications provided

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: November 12, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014