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

January 3, 2006
January 27, 2009
March 2006
September 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00271713 on ClinicalTrials.gov Archive Site
Not Provided
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Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis, Postmenopausal
  • Drug: ibandronate, calcium and vitamin D
    1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
  • Drug: placebo,calcium and vitamin D
    2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
  • Active Comparator: ibandronate
    150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
    Intervention: Drug: ibandronate, calcium and vitamin D
  • Placebo Comparator: 2
    placebo monthly plus 500mg calcium and 800 UI vitamin D daily
    Intervention: Drug: placebo,calcium and vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Female
60 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00271713
ML 19472
No
Charite University, Berlin, Germany, center for muscle and bone research
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Dieter Felsenberg, Prof. Dr. Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
Charite University, Berlin, Germany
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP