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

Charité University Medicine Berlin

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: ibandronate, calcium and vitamin D

Drug: placebo,calcium and vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT00271713

ML 19472

Details and patient eligibility

About

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

Enrollment

70 patients

Sex

Female

Ages

60 to 75 years old

Volunteers

No 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