Clinical trial NCT00271713: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Keywords: bone structure
ibandronate
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 70
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: BV/TV and trab. Sp. measured by 3D pQCT device
timeFrame: Baseline and after 3, 6, 9 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Study officials:
affiliation: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
name: Dieter Felsenberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: