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

January 27, 2009 updated by: Charite University, Berlin, Germany

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria

January 3, 2006

First Posted (Estimate)

January 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML 19472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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