Clinical trial NCT00129623: A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
Official title: Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Menopausal Osteopenia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 160
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* women 45-60 years of age;
* post-menopausal;
* ambulatory.

Exclusion Criteria:

* vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
* low-trauma osteoporotic fracture in any other bone;
* breast cancer diagnosed within last 20 years;
* other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
* treatment with any bisphosphonate within last 2 years;
* treatment with other drugs affecting bone metabolism within last 6 months.

Primary outcomes:
measure: Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
timeFrame: Baseline and Month 12
measure: Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
timeFrame: Baseline and Month 12
measure: Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
timeFrame: Baseline and Month 12
measure: Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
timeFrame: Baseline and 3, 6 and 12 months
measure: Absolute Change From Baseline in sCTX
timeFrame: Baseline and 3, 6, 12 months
measure: Percentage of Responders
timeFrame: Up to 12 months
measure: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 15 days after end of study treatment (Approximately 2 years)
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Screening up to 12 months
Other outcomes:
Locations:
city: Lakewood
country: United States
state: Colorado
city: Stuart
country: United States
state: Florida
city: Bethesda
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Amarillo
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: