Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary aim of the study is the comparative effect of zolendronic acid versus denosumab on serum sclerostin levels in postmenopausal women with low bone mass.

Secondary aims are their comparative effect on serum dickkopf-1, osteoprotegerin, receptor activator of nuclear factor kappaB ligand (RANKL) and bone turnover markers (procollagen type I N-terminal peptide [PINP] and C-terminal cross-linking telopeptide of type I collagen [CTX]).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aristotle University Of Thessaloniki
• Collaborators: 251 Hellenic Air Force & VA General Hospital; 424 General Military Hospital
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Caucasian postmenopausal women older than 40 years

• Low bone mass at lumbar spine (L2-L4) or femoral neck (BMD T-score of ≤ -2.0) or BMD T-score of > -2.0 coexistent with low-energy fracture of vertebral, femoral neck or forearm

• Patient's informed consent to participate

Exclusion Criteria:

• Secondary osteoporosis

• Any bone and mineral disorder other than osteoporosis, including primary or secondary hyperparathyroidism, Paget's disease of bone, osteogenesis imperfecta, rheumatologic diseases, paraplegia, chronic immobilization

• Severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2) or liver or kidney transplantation

• Premature ovarian failure

• Uncontrolled thyroid disease

• Any malignancy

• Any musculoskeletal injury or surgical procedure 6 months prior to baseline

• Dental surgery or teeth removed 3 months prior to baseline or plan to

• History or concomitant medications that could affect bone metabolism, including immunosuppressive, anticonvulsant, antiviral and anti-tuberculosis agents, addictive drugs, corticosteroids, non-steroidal anti-inflammatory drugs, amiodarone, thiazolidinediones, interferon, metronidazole, and tamoxifen