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

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Postmenopausal

Intervention: ibandronate, calcium and vitamin D (Drug); placebo,calcium and vitamin D (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Dieter Felsenberg, Prof. Dr., Principal Investigator, Affiliation: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: BV/TV and trab. Sp. measured by 3D pQCT device

Eligibility

Minimum age: 60 Years. Maximum age: 75 Years. Gender(s): Female.

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

Locations and Contacts

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

Homepage of the Centre for Muscle and Bone Research

Starting date: March 2006
Last updated: January 27, 2009

Page last updated: August 23, 2015

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