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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis Postmenopausal

Intervention: alendronate sodium (+) cholecalciferol (Drug); Comparator: Alendronate sodium (Fosamax) (Drug); Comparator: Calcium (Dietary Supplement)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


To demonstrate the efficacy/safety of Fosamax Plus D

Clinical Details

Official title: A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment

Secondary outcome: Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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

Locations and Contacts

Additional Information

Starting date: March 2008
Last updated: July 21, 2015

Page last updated: August 20, 2015

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