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Completed

NCT Number: NCT00729651

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

To demonstrate the efficacy/safety of Fosamax Plus D

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Key information

Conditions

Osteoporosis Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alendronate sodium (+) cholecalciferol

Drug

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

Other names: Fosamax Plus D

Comparator: Alendronate sodium (Fosamax)

Drug

Alendronate sodium; tablet, once weekly, for 16 weeks

Comparator: Calcium

Dietary Supplement

500 mg oral tablet calcium once daily, for 16 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment

    Time frame: Baseline and 16 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2008
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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