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

Study Overview
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Brief Summary
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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

Official Title
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Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: ibandronate, calcium and vitamin D
* Drug: placebo,calcium and vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ibandronate<br>150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily | Drug: ibandronate, calcium and vitamin D<br>* 1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or<br>|
| Placebo Comparator: 2<br>placebo monthly plus 500mg calcium and 800 UI vitamin D daily | Drug: placebo,calcium and vitamin D<br>* 2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BV/TV and trab. Sp. measured by 3D pQCT device |  | Baseline and after 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone structure, ibandronate