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

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271713
• Other study ID #: ML 19472
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2006
• Last updated: January 27, 2009
• Start date: March 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2009
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• ibandronate, calcium and vitamin D
1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
• placebo,calcium and vitamin D
2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily

Locations

Country	Name	City	State
Germany	Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BV/TV and trab. Sp. measured by 3D pQCT device		Baseline and after 3, 6, 9 and 12 months	No

External Links

•   Homepage of the Centre for Muscle and Bone Research