NCT00271713

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 28, 2009

Status Verified

January 1, 2009

Enrollment Period

1.5 years

First QC Date

January 3, 2006

Last Update Submit

January 27, 2009

Conditions

Osteoporosis, Postmenopausal

Keywords

bone structureibandronate

Outcome Measures

Primary Outcomes (1)

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

    Baseline and after 3, 6, 9 and 12 months

Study Arms (2)

ibandronate

ACTIVE COMPARATOR

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

Drug: ibandronate, calcium and vitamin D

2

PLACEBO COMPARATOR

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

Drug: placebo,calcium and vitamin D

Interventions

ibandronate, calcium and vitamin DDRUG

1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or

ibandronate
placebo,calcium and vitamin DDRUG

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

2

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • DpQCT measurable at both skeletal sites, distal tibia and radius

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic AcidCalciumVitamin D

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Dieter Felsenberg, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

March 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 28, 2009

Record last verified: 2009-01

Locations

DE(1)