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

NCT01572545 | Completed DMC

• 1 other identifier: PolyzosAnastasilakis
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 3

Brief 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 \[CTX\]).

Conditions

Postmenopausal Osteoporosis

Keywords

bone turnover; denosumab; postmenopausal osteoporosis; sclerostin; zolendronic acid

Outcome Measures

Primary Outcomes (1)

• Sclerostin

  Serum sclerostin levels

  12 weeks

Secondary Outcomes (4)

• Dickkopf-1

  12 weeks

• OPG/RANKL

  12 weeks

• Calcium metabolism

  12 weeks

• Bone turnover

  12 weeks

Study Arms (2)

Denosumab

EXPERIMENTAL

Drug: Denosumab

Zoledronic Acid

EXPERIMENTAL

Drug: Zoledronic acid

Interventions

Denosumab DRUG

Denosumab (injection), 60 mg, administered as a single subcutaneous injection once

Also known as: Prolia

Denosumab

Zoledronic acid DRUG

Zoledronic acid (vial), 5 mg, administered once as a single 15- to 30-minute intravenous infusion

Also known as: Aclasta

Zoledronic Acid

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• 424 General Military Hospital: collaborator
• 251 Hellenic Air Force & VA General Hospital: collaborator

Study Sites (3)

251 Hellenic Air Force Hospital

Athens, Attikis, Greece

Location

424 General Military Hospital

Thessaloniki, Thessaloniki, Greece

Location

Second Medical Clinic, Medical School, Aristotle University of Thessaloniki, Ippokration Hospital

Thessaloniki, Thessaloniki, Greece

Location

Related Publications (5)

• Anastasilakis AD, Polyzos SA, Makras P, Sakellariou GT, Bisbinas I, Gkiomisi A, Delaroudis S, Gerou S, Ballaouri I, Oikonomou D, Papapoulos SE. Acute phase response following intravenous zoledronate in postmenopausal women with low bone mass. Bone. 2012 May;50(5):1130-4. doi: 10.1016/j.bone.2012.02.006. Epub 2012 Feb 15.

  PMID: 22366634 BACKGROUND

• Anastasilakis AD, Polyzos SA, Anastasilakis CD, Toulis KA, Makras P. Denosumab and bisphosphonates: rivals or potential "partners"? A "hybrid" molecule hypothesis. Med Hypotheses. 2011 Jul;77(1):109-11. doi: 10.1016/j.mehy.2011.03.039. Epub 2011 Apr 8.

  PMID: 21482033 BACKGROUND

• Polyzos SA, Anastasilakis AD, Bratengeier C, Woloszczuk W, Papatheodorou A, Terpos E. Serum sclerostin levels positively correlate with lumbar spinal bone mineral density in postmenopausal women--the six-month effect of risedronate and teriparatide. Osteoporos Int. 2012 Mar;23(3):1171-6. doi: 10.1007/s00198-010-1525-6. Epub 2011 Jan 11.

  PMID: 21305266 BACKGROUND

• Anastasilakis AD, Toulis KA, Polyzos SA, Terpos E. RANKL inhibition for the management of patients with benign metabolic bone disorders. Expert Opin Investig Drugs. 2009 Aug;18(8):1085-102. doi: 10.1517/13543780903048929.

  PMID: 19558335 BACKGROUND

• Anastasilakis AD, Toulis KA, Goulis DG, Polyzos SA, Delaroudis S, Giomisi A, Terpos E. Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis. Horm Metab Res. 2009 Oct;41(10):721-9. doi: 10.1055/s-0029-1224109. Epub 2009 Jun 17.

  PMID: 19536731 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Sclerosteosis

Interventions

Denosumab; Zoledronic Acid

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stergios A Polyzos, MD, MSc, PhD

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Athanasios D Anastasilakis, MD, PhD

  424 General Military Hospital

  PRINCIPAL INVESTIGATOR

• Polyzois Makras, MD, PhD

  251 Hellenic Air Force & VA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 6, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

GR (3)