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

Osteoporosis Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729651
• Other study ID #: 0217A-263
• Secondary ID: MK0217A-2632008_
• Status: Completed
• Phase: Phase 4
• Start date: March 20, 2008
• Est. completion date: April 10, 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the efficacy/safety of Fosamax Plus D

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: April 10, 2009
• Est. primary completion date: April 10, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Postmenopausal
• Osteoporosis, Postmenopausal

Intervention

Drug:
• alendronate sodium (+) cholecalciferol
Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment		16 weeks
Secondary	Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment		Baseline and 16 weeks