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 - SPIMOS 3D

Phase 1

• Conditions: Postmenopausal osteoporosis; Classification code 10031285

• Registration Number: EUCTR2005-003195-38-DE
• Lead Sponsor: Center for Muscle and Bone Research of the Charité Universitaetsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Study Completion: 2007-11-15
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

•Age between 60 and 75 years
•Menopause > 5 years
•Measurable BMD of the spine and hip by DXA (e.g. no metal devices or severe degenerative changes)
•BMD of spine (L1 – L4) or hip = -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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•spine or hip BMD = -3,5 SD T-Score measured by DXA
•Vertebral fractures
•Multiple (>2) low trauma peripheral fractures
•Employees of the Centre of Muscle and Bone Research, or their relatives

Medical history
•Disease/disorder known to influence bone metabolism: chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperpara-thyroidism, Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment
•History of major upper gastro-intestinal (GI) disease
•Diagnosed malignant disease within the previous 10 years (except successfully resected basal cell cancer)

Previous medication
•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 Vit. D analogs/metabolites, calcitonin)
?Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate

Laboratory
•Serum total Ca 2+ < 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified