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


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Flunisolide Oral Inhalation

Aero-Bid-M; Aerobid




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

This study is not yet open for patient recruitment.
Verified by Charite University, Berlin, Germany December 2005

Sponsored by: 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: oral ibandronate 150 mg monthly
Phase IV

MedlinePlus related topics:  Osteoporosis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures

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

Expected Total Enrollment:  62

Study start: January 2006;  Expected completion: February 2008
Last follow-up: August 2007;  Data entry closure: December 2007

Eligibility

Ages Eligible for Study:  60 Years   -   75 Years,  Genders Eligible for Study:  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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00271713

Hendrikje Boerst, Dipl.Wiss.org.      +49/30/84454745    hendrikje.boerst@charite.de

Germany
      Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin,  12200,  Germany
Dieter Felsenberg, Prof. Dr.  +49/30/84453046    hendrikje.boerst@charite.de 
Dieter Felsenberg, Prof. Dr.,  Principal Investigator
Oliver Bock, Dr.,  Sub-Investigator

Study chairs or principal investigators

Dieter Felsenberg, Prof. Dr.,  Principal Investigator,  Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany   

More Information

Study ID Numbers:  ML 19472
Last Updated:  January 3, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00271713
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2006-01-10

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Page Updated: June 1, 2005
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