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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00271713
First received: January 3, 2006
Last updated: January 27, 2009
Last verified: January 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Vitamins
Vitamin D
Ergocalciferols
Ibandronic acid
Calcium, Dietary
Diphosphonates
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014