A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

• ClinicalTrials.gov Identifier: NCT00545051
• Recruitment Status: Completed
• First Posted: October 17, 2007
• Results First Posted: May 12, 2016
• Last Update Posted: May 12, 2016
• Sponsor: Hoffmann-La Roche
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition or disease	Intervention/treatment	Phase
Postmenopausal Osteoporosis	Drug: Placebo; Drug: ibandronate	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
• Study Start Date: May 2006
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ibandronate; Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.	Drug: ibandronate; 150mg po monthly for 12 months; Other Name: Bonviva/Boniva
Placebo Comparator: Placebo; Participants received monthly oral placebo for 12 months.	Drug: Placebo; po monthly for 12 months

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline and Month 12 ]
   Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.

Secondary Outcome Measures :

1. Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 [ Time Frame: Baseline and Month 6 ]
   Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.
2. Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 [ Time Frame: Baseline and Months 6 and 12 ]
   Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.
3. Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 [ Time Frame: Baseline and Months 1, 6 and 12 ]
   Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.
4. Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months [ Time Frame: Month 6 ]
   Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• post-menopausal women, 50-85 years of age;
• any inflammatory rheumatoid disease including polymyalgia rheumatica;
• receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

• previous treatment with an iv bisphosphonate at any time;
• previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
• treatment with parathyroid hormone in last 2 years;
• inability to stand or sit in an upright position for at least 60 minutes;
• inability to swallow a tablet whole;
• history of major gastrointestinal disease.

Contacts and Locations

Locations

Finland

Helsinki, Finland, 00100

Helsinki, Finland, 00290

Helsinki, Finland, 00350

Hyvinkää, Finland, 05800

Hämeenlinna, Finland, 13530

Jyvaeskylae, Finland, 10100

Jyväskylä, Finland, 40100

Kuopio, Finland, 70211

Lahti, Finland, 15110

Oulu, Finland, 90029

Oulu, Finland, 90100

Tampere, Finland, 33100

Tampere, Finland, 33101

Turku, Finland, 20100

Vantaa, Finland, 01300

Sponsors and Collaborators

Hoffmann-La Roche

GlaxoSmithKline

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00545051
• Other Study ID Numbers: ML20088
• First Posted: October 17, 2007
• Results First Posted: May 12, 2016
• Last Update Posted: May 12, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Ibandronic Acid; Bone Density Conservation Agents; Physiological Effects of Drugs