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Postmenopausal OsteoporosisDenoZolNCT01572545

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

A study testing Denosumab and Zoledronic acid in people with Postmenopausal Osteoporosis, run by Aristotle University Of Thessaloniki at 3 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
Denosumab and Zoledronic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
3 sitesGreece
Study dates
Apr 2012to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Greece3 sites

  • 251 Hellenic Air Force Hospital

    Athens, Attikis

  • 424 General Military Hospital

    Thessaloniki, Thessaloniki

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

    Thessaloniki, Thessaloniki

Other trials in Greece

About this study

Official title: Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin Levels of Postmenopausal Women With Low Bone Mass: A Multicenter, Randomized, Head-to-head Clinical Trial

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]).

Read the detailed description

Osteoporosis is the most common bone disease, caused by a relatively increased rate of bone resorption by the osteoclasts that exceeds the rate of bone formation by the osteoblasts, resulting in net loss of bone mass. To-date, antiresorptive agents, which inhibit osteoclast activity and induce their apoptosis, are considered as the cornerstone of osteoporosis prevention and treatment.

Bisphosphonates currently represent the first line antiresorptive agents for the management of postmenopausal osteoporosis. Zoledronic acid is considered to-date the most potent bisphosphonate. A once-yearly infusion of intravenous zoledronic acid decreases bone turnover, improves bone density and decreases the vertebral and non-vertebral fracture risk.

Most recently, denosumab (AMG-162) has been launched for the treatment of postmenopausal osteoporosis. Denosumab, a fully human monoclonal IgG2 antibody against human RANKL, specifically binds and neutralizes the receptor activator of nuclear factor kappaB ligand (RANKL) in order to decrease bone resorption and subsequent bone loss. Subcutaneous administration of denosumab every six months decreases bone turnover markers, increases bone mineral density and reduces the vertebral and non-vertebral fracture risk.

The role of sclerostin in bone metabolism is emerging. Sclerostin is the secreted expression of the SOST gene. In adult human bone, sclerostin is expressed only by osteocytes and inhibits bone formation by osteoblasts. It has been proposed that sclerostin expression by newly embedded osteocytes at the onset of osteoid mineralization may serve as a negative feedback signal on osteoblasts to prevent overfilling of the basic multicellular unit.

Although zoledronic acid and denosumab are currently regarded as the most potent antiresorptive agents, there is no head-to-head comparative study. This study primarily aims to the comparative effect of zoledronic acid and denosumab on serum sclerostin levels and secondarily on serum dickkopf-1, osteoprotegerin, RANKL and bone turnover markers (procollagen type I N-terminal peptide [PINP] and C-terminal cross-linking telopeptide of type I collagen [CTX]).

Being tested
Denosumab, Zoledronic acid
Keywords
bone turnover, denosumab, postmenopausal osteoporosis, sclerostin, zolendronic acid
Medical subject headings
Osteoporosis, Postmenopausal, Sclerosteosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DenosumabDrug

    Also called Prolia

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

  • Zoledronic acidDrug

    Also called Aclasta

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

Study groups in NCT01572545
Study groupRoleWhat they receive
DenosumabExperimentalNot described
Receives: Drug: Denosumab
Zoledronic AcidExperimentalNot described
Receives: Drug: Zoledronic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sclerostin

    Serum sclerostin levels

    Measured: 12 weeks

Secondary outcomes (4)

  1. Dickkopf-1

    Serum dickkopf-1 (DKK-1) levels

    Measured: 12 weeks

  2. OPG/RANKL

    Serum osteoprotegerin (OPG) and receptor activator of nuclear factor kappaB ligand (RANKL) levels

    Measured: 12 weeks

  3. Calcium metabolism

    Serum calcium, phosphate, intact parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25OHD)

    Measured: 12 weeks

  4. Bone turnover

    Serum bone turnover markers (total alkaline phosphatase [TSAP], type I N-terminal peptides [PINP] και C-terminal cross-linking telopeptide of type I collagen [CTX])

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572545
Sponsor's protocol ID
PolyzosAnastasilakis
Acronym
DenoZol
Status last verified
Jan 2013
First submitted
3 Apr 2012
Last updated
17 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22366634

  • 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.

    PubMed 21482033

  • 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.

    PubMed 21305266

  • 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.

    PubMed 19558335

  • 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.

    PubMed 19536731

Questions about this trial

What is this clinical trial studying?

A study testing Denosumab and Zoledronic acid in people with Postmenopausal Osteoporosis, run by Aristotle University Of Thessaloniki at 3 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sclerostin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01572545, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.

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