Estudio de fase 2, multicéntrico, aleatorizado, controlado con producto activo, de grupos paralelos, búsqueda de dosis y de la seguridad de la proteína morfogenética de hueso humano recombinante 2 (rhBMP-2)/matriz de fosfato cálcico (CPM) en pacientes con disminución de la densidad mineral ósea

• Conditions: Sujetos con disminución de la densidad mineral ósea (DMO) en riesgo de fractura de cadera; MedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis; MedDRA version: 9.1Level: PTClassification code 10031282Term: Osteoporosis

• Registration Number: EUCTR2007-007456-34-ES
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-21
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. Community-dwelling, ambulatory (with or without assistive device), postmenopausal woman, age ?65 years.

2. BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least 1 of the following risk factors is also present.
- Age ?75 years
-Family (maternal) history of fragility fracture
-Previous fragility fracture (self) after 45 years

3. Bilaterally intact proximal femora, without evidence of acute fracture, surgical hardware, or prosthetic implant.

4. Subjects may either be treatment naive or on a previously established regimen (?1 year, but <5 years duration) of bisphosphonate therapy.

5. Subjects must be willing to comply with 1 of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Pagets disease, vitamin D deficiency [<20 ng/mL], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
2.Previous use of agents that can be considered bone anabolic (eg, parathyroid hormone (PTH), growth hormone, anabolic steroids, or sodium fluoride at bone therapeutic doses).
3.Previous use of SERMs, HRT, or calcitonin within the past 12 months.
4.Continuous or intermittent disease that requires systemic glucocorticosteroid treatment within the past 6 months (eg, chronic obstructive pulmonary disease, asthma).
5.Active infection at any anatomical site.
6.Evidence of unstable clinically relevant disease (eg, cardiovascular, hepatic, renal, or thyroid disease).
7.Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
8.Body mass index (BMI) >35 kg/m2.
9.Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.
10.Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ?1.5 times the upper limit of normal (ULN) at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified