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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00541658
Date of registration:	05/10/2007
Prospective Registration:	No
Primary sponsor:	Warner Chilcott
Public title:	A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Scientific title:	A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.
Date of first enrolment:	October 2007
Target sample size:	923
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00541658
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Argentina	Belgium	Canada	Estonia	France	Hungary	Poland	United States

Contacts

Name:	Ana Balske, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Procter and Gamble

Key inclusion & exclusion criteria

Inclusion Criteria:

- Female: 50 years of age or older

- >5 years since last menses natural or surgical

- have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or
have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean
value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

- history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

- BMI >32 kg/m

- use of medications within 3 months of starting study drug that impact bone metabolism
such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and
parathyroid hormone

- hypocalcemia or hypercalcemia of any cause

- markedly abnormal clinical laboratory measurements that are assessed as clinically
significant by the investigator

Age minimum: 50 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Postmenopausal Osteoporosis

Intervention(s)

Drug: risedronate

Primary Outcome(s)

Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population [Time Frame: 52 weeks / Endpoint]

Secondary Outcome(s)

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population [Time Frame: Week 26]

Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population [Time Frame: Week 104]

Number of Patients With No New Fractured Vertebra, Week 52 [Time Frame: Week 52]

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population [Time Frame: Week 104]

Number of Patients With No New Fractured Vertebra, Week 104 [Time Frame: Week 104]

Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population [Time Frame: Week 104]

Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population [Time Frame: Week 26]

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population [Time Frame: Week 52]

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population [Time Frame: Week 52]

Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population [Time Frame: Week 52]

Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population [Time Frame: Week 104]

Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population [Time Frame: Week 26]

Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population [Time Frame: Week 104]

Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population [Time Frame: Week 26]

Number of Patients With at Least One New Fractured Vertebra, Week 52 [Time Frame: Week 52]

Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population [Time Frame: Week 52]

Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population [Time Frame: Week 52]

Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population [Time Frame: Week 104]

Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population [Time Frame: Week 52]

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population [Time Frame: Week 26]

Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population [Time Frame: Week 26]

Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population [Time Frame: Week 104 / Endpoint]

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population [Time Frame: Week 104]

Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population [Time Frame: Week 13]

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population [Time Frame: Week 52]

Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population [Time Frame: Week 13]

Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population [Time Frame: Week 13]

Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population [Time Frame: Week 26]

Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population [Time Frame: Week 104]

Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population [Time Frame: Week 52]

Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population [Time Frame: Week 52]

Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population [Time Frame: Week 52 / Endpoint]

Secondary ID(s)

2007008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	21/06/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00541658

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