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

COMPLETEDPHASE4

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

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

NCT00271713•Charite University, Berlin, Germany

View on ClinicalTrials.gov

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

Eligibility

Age

60 - 75 years

Sex

FEMALE

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
+9 more criteria

Locations (1)

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

Berlin, Germany

Key Dates

Start Date

March 1, 2006

Primary Completion Date

September 1, 2007

Completion Date

September 1, 2007

Last Updated

January 28, 2009

Enrollment

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

ibandronate, calcium and vitamin D

DRUG

placebo,calcium and vitamin D

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

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RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects