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

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00271713

Purpose

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

Condition	Intervention	Phase
Osteoporosis, Postmenopausal	Drug: ibandronate, calcium and vitamin D Drug: placebo,calcium and vitamin D	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Fractures Osteoporosis Vitamin D

Drug Information available for: Ibandronic acid Ibandronate sodium Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

BV/TV and trab. Sp. measured by 3D pQCT device [ Time Frame: Baseline and after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	March 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ibandronate 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily	Drug: ibandronate, calcium and vitamin D 1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
Placebo Comparator: 2 placebo monthly plus 500mg calcium and 800 UI vitamin D daily	Drug: placebo,calcium and vitamin D 2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Eligibility

Ages Eligible for Study:	60 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271713

Locations

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

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Dieter Felsenberg, Prof. Dr.

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

More Information

Additional Information:

Homepage of the Centre for Muscle and Bone Research This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Charite University, Berlin, Germany, center for muscle and bone research
ClinicalTrials.gov Identifier:	NCT00271713 History of Changes
Other Study ID Numbers:	ML 19472
Study First Received:	January 3, 2006
Last Updated:	January 27, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

bone structure
ibandronate

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Calcium, Dietary
Vitamin D

Ergocalciferols
Diphosphonates
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012