A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00129623
First received: August 11, 2005
Last updated: December 5, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Post-Menopausal Osteopenia
Drug: Placebo
Drug: ibandronate [Bonviva/Boniva]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)


Secondary Outcome Measures:
  • Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.

  • Relative Change From Baseline in Mean Proximal Femur BMD at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.

  • Absolute Change From Baseline in BMD of the Proximal Femur at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.

  • Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX) [ Time Frame: Baseline and 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.

  • Absolute Change From Baseline in sCTX [ Time Frame: Baseline and 3, 6, 12 months ] [ Designated as safety issue: No ]
    Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.

  • Percentage of Responders [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.

  • Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 15 days after end of study treatment (Approximately 2 years) ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

  • Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Screening up to 12 months ] [ Designated as safety issue: No ]
    Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].


Enrollment: 160
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 1 year
Placebo Comparator: 2 Drug: Placebo
po monthly for 1 year

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129623

Locations
United States, Colorado
Lakewood, Colorado, United States, 80227
United States, Florida
Stuart, Florida, United States, 34996
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Michigan
Detroit, Michigan, United States, 48236
United States, Missouri
St Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Cincinnati, Ohio, United States, 45224
United States, Oregon
Portland, Oregon, United States, 97213
United States, Texas
Amarillo, Texas, United States, 79124
United States, Virginia
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00129623     History of Changes
Other Study ID Numbers: BA18492 
Study First Received: August 11, 2005
Results First Received: December 5, 2015
Last Updated: December 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ibandronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 04, 2016