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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-20

Study Completion Date

2009-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To demonstrate the efficacy/safety of Fosamax Plus D

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

NCT00221312

Perimenopausal Bone Loss

COMPLETED

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

NCT01350934

Osteoporosis, Postmenopausal

COMPLETED PHASE4

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

NCT00692913

Osteoporosis

COMPLETED PHASE3

FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

NCT01065779

Osteoporosis

COMPLETED

Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )

NCT00236002

Osteoporosis

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis Postmenopausal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Alendronate sodium/Cholecalciferol

Group Type EXPERIMENTAL

alendronate sodium (+) cholecalciferol

Intervention Type DRUG

Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks

Comparator: Calcium

Intervention Type DIETARY_SUPPLEMENT

500 mg oral tablet calcium once daily, for 16 weeks

2

Alendronate sodium

Group Type ACTIVE_COMPARATOR

Comparator: Alendronate sodium (Fosamax)

Intervention Type DRUG

Alendronate sodium; tablet, once weekly, for 16 weeks

Comparator: Calcium

Intervention Type DIETARY_SUPPLEMENT

500 mg oral tablet calcium once daily, for 16 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

alendronate sodium (+) cholecalciferol

Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks

Intervention Type DRUG

Comparator: Alendronate sodium (Fosamax)

Alendronate sodium; tablet, once weekly, for 16 weeks

Intervention Type DRUG

Comparator: Calcium

500 mg oral tablet calcium once daily, for 16 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fosamax Plus D

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No