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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00918749
Other study ID # 2009003
Secondary ID
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


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
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