Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

Postmenopausal Osteoporosis Clinical Trial

Official title:

Study Assessing the Efficacy, Safety, and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release Risedronate Formulations Compared to 150 mg Once-a-month Immediate-release Risedronate for 3 Months in Postmenopausal Women Age 45-80

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00918749
• Other study ID #: 2009003
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2009
• Last updated: June 1, 2015
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: June 2015
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• female, 45 to 80 years of age, in good general health

• postmenopausal =2 years, surgically or naturally

• body mass index less than or equal to 32 kg/m^2 at screening

Exclusion Criteria:

• no use within 3 months prior, nor use for more than 1 month at any time within 6 months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor modulators (SERMs), or estrogen-related drugs, progestins, calcitonin, vitamin D supplements (>1200 IU per day), calcitriol, calcidiol, or alfacalcidol at any dose, any bisphosphonate. fluoride (=10 mg/day), strontium (=50 mg/day), parathyroid hormone, investigational bone active agents.

• allergic or abnormal reactions to bisphosphonates

• history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6 month remission

• positive pregnancy test

• no depot injection >10,000 IU vitamin D in previous 9 months.

• no history of GI disease that requires medication, or history of Crohn's disease, ulcerative colitis, diverticular disease, polyps, or surgery that could have changed GI structure or motility.

• no history of frequent diarrhea or constipation that requires regular laxative use.

• no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years, major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension, cardiovascular, hepatic, renal or GI disease.

• no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic reaction to bisphosphonates

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• 150 mg
150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
• 75 mg
75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
• 100 mg
100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Daytona	Florida
United States	Research Site	Evansville	Indiana
United States	Research Site	Ft. Myers	Florida
United States	Research Site	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population	Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.	Month 4	No
Secondary	Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population		2 months	No
Secondary	Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population		3 months	No
Secondary	Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.	2 months	No
Secondary	Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	ITT Population	3 months	No
Secondary	Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	ITT Population	4 months	No
Secondary	Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	ITT Population	2 months	No
Secondary	Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	ITT Population	3 months	No
Secondary	Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	ITT Population	4 months	No