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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2007

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: ibandronate
    • 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
  • Placebo Comparator: 2
    • placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Clinical Trial Outcome Measures

Primary Measures

  • BV/TV and trab. Sp. measured by 3D pQCT device
    • Time Frame: Baseline and after 3, 6, 9 and 12 months

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 60 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Charite University, Berlin, Germany, center for muscle and bone research
  • Overall Official(s)
    • Dieter Felsenberg, Prof. Dr., Principal Investigator, Centre for Muscle and Bone Research, Charité – Campus Benjamin Franklin, Berlin, 12200, Germany

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