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

NCT ID: NCT00271713

Last Updated: 2009-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-09-30

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

Conditions

Osteoporosis, Postmenopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ibandronate

150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily

Group Type: ACTIVE_COMPARATOR

ibandronate, calcium and vitamin D

Intervention Type: DRUG

1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or

2

placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Group Type: PLACEBO_COMPARATOR

placebo,calcium and vitamin D

Intervention Type: DRUG

2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Interventions

ibandronate, calcium and vitamin D

1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or

Intervention Type: DRUG

placebo,calcium and vitamin D

2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

center for muscle and bone research

Principal Investigators

Dieter Felsenberg, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany

Locations

Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin

Berlin, , Germany

Countries

Germany

Other Identifiers

ML 19472

Identifier Type: -

Identifier Source: org_study_id