Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)

Phase 4

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: ibandronate, calcium and vitamin D; Drug: placebo,calcium and vitamin D

• Registration Number: NCT00271713
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Efficacy:

To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.

Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT.

Safety:

To assess the tolerability and safety of ibandronate therapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-03
• Study First Submitted QC: 2006-01-03
• Study First Posted: 2006-01-04
• Study Start: 2006-03
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Age between 60 and 75 years
• Menopause > 5 years
• Spine (L1 - L4) or hip BMD ≤ -2.0 and > -3.5 SD T-score measured by DXA
• Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
• Written informed consent
• 3DpQCT measurable at both skeletal sites, distal tibia and radius

Exclusion Criteria

• Spine or hip BMD ≤ -3,5 SD T-Score measured by DXA
• Vertebral fractures
• Multiple (>2) low trauma peripheral fractures
• Disease/disorder known to influence bone metabolism
• History of major upper gastro-intestinal (GI) disease
• Diagnosed malignant disease within the previous 10 years
• Previous treatment with a bisphoshonate at any time
• Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration)
• Treatment with PTH and similar agents or strontium ranelate at any time
• Treatment with other drugs affecting bone metabolism within the last 6 months
• Chronic systemic corticosteroid treatment
• Estrogens, progestins, SERMs, anabolic steroids, active vitamin D analogues/metabolites, calcitonin
• Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
• Total serum calcium < 2.2 mmol/l or > 2.6 mmol/l
• Vitamin D deficiency (serum 25-hydroxy vitamin D < 12 ng/ ml)
• ALT above triple upper limit of normal range
• Renal impairment (serum creatinine > 210 µmol/l)
• Contra-indications for ibandronate, calcium or vitamin D
• Employees of the Centre for Muscle and Bone Research, or their relatives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibandronate	ibandronate, calcium and vitamin D	150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
2	placebo,calcium and vitamin D	placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Primary Outcome Measures

Name	Time	Method
BV/TV and trab. Sp. measured by 3D pQCT device	Baseline and after 3, 6, 9 and 12 months

Trial Locations

Locations (1)

Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany