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

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ibandronate, calcium and vitamin D
placebo,calcium and vitamin D
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring bone structure, ibandronate

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ibandronate

2

Arm Description

150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily

placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Outcomes

Primary Outcome Measures

BV/TV and trab. Sp. measured by 3D pQCT device

Secondary Outcome Measures

Full Information

First Posted
January 3, 2006
Last Updated
January 27, 2009
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00271713
Brief Title
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
Keywords
bone structure, ibandronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibandronate
Arm Type
Active Comparator
Arm Description
150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo monthly plus 500mg calcium and 800 UI vitamin D daily
Intervention Type
Drug
Intervention Name(s)
ibandronate, calcium and vitamin D
Intervention Description
1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
Intervention Type
Drug
Intervention Name(s)
placebo,calcium and vitamin D
Intervention Description
2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
Primary Outcome Measure Information:
Title
BV/TV and trab. Sp. measured by 3D pQCT device
Time Frame
Baseline and after 3, 6, 9 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Felsenberg, Prof. Dr.
Organizational Affiliation
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany

12. IPD Sharing Statement

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

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