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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271713

Enrollment

Registered

2006-01-04

Start date

2006-03-31

Completion date

2007-09-30

Last updated

2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Keywords

bone structure, ibandronate

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

Interventions

DRUGibandronate, calcium and vitamin D

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

DRUGplacebo,calcium and vitamin D

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

60 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
BV/TV and trab. Sp. measured by 3D pQCT device	Baseline and after 3, 6, 9 and 12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026