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

Organon

Status and phase

Completed

Phase 4

Conditions

Osteoporosis Postmenopausal

Treatments

Dietary Supplement: Comparator: Calcium

Drug: alendronate sodium (+) cholecalciferol

Drug: Comparator: Alendronate sodium (Fosamax)

Study type

Interventional

Funder types

Industry

Identifiers

0217A-263

2008_015

MK0217A-263

Details and patient eligibility

About

To demonstrate the efficacy/safety of Fosamax Plus D

Enrollment

343 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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