Clinical trial NCT00918749: Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 205
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Month 4
Secondary outcomes:
measure: Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
timeFrame: 2 months
measure: Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
timeFrame: 3 months
measure: 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
timeFrame: 2 months
measure: Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
timeFrame: 3 months
measure: Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
timeFrame: 4 months
measure: Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
timeFrame: 2 months
measure: Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
timeFrame: 3 months
measure: Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
timeFrame: 4 months
Other outcomes:
Locations:
city: Daytona
country: United States
facility: Research Site
state: Florida
city: Ft. Myers
country: United States
facility: Research Site
state: Florida
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Procter and Gamble
name: Chantell Wilson, PhD
role: STUDY_DIRECTOR
References: