Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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2 March 2015 |
Main ID: |
EUCTR2012-001821-28-PL |
Date of registration:
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17/12/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
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Scientific title:
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A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates |
Date of first enrolment:
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17/01/2013 |
Target sample size:
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620 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001821-28 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Australia
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Belgium
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Canada
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Denmark
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Germany
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Poland
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Spain
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United States
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Contacts
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Name:
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IHQ Medical Info – Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
CH-6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Info – Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
CH-6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Subject or subject’s legally acceptable representative has provided informed consent prior to any study specific procedure(s)
- Ambulatory postmenopausal women. Ambulatory is defined as women who are able to walk, not bedridden; postmenopause is defined as no vaginal bleeding or spotting for at least 12 months prior to screening.
- Age 55 years or older
- Received oral bisphosphonate therapy for OP for at least 2 years immediately prior to screening visit
- Screening BMD (g/cm2) values at the lumbar spine, total hip or femoral neck; values of equal to or less than those listed in the protocol. Eligibility will be determined by a local reading of the DXAs at the investigator site. At least 2 lumbar vertebrae and one hip must be evaluable by DXA at the screening visit.
- Serum CTX value of = 0.5 ng/mL at the screening visit as determined by central laboratory Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 440
Exclusion criteria: - Height, weight or girth which may preclude accurate DXA measurements
- Received other OP treatment or bone active treatment with the following guidelines
• administration of denosumab or zoledronic acid at any time
• administration of the following within the last 5 years
o IV bisphosphonate other than zoledronic acid
o fluoride or strontium at doses approved for OP
o PTH or PTH derivatives within the last year
Abnormalities of the following per central laboratory reference ranges:
• vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be allowed and subjects may be re-screened
• hypercalcemia
• elevated transaminases = 2.0 x upper limits of normal (ULN)
Administration of any of the following treatment within 3 months of screening:
• any selective estrogen receptor modulator (estrogen agonist antagonist)
• tibolone
• anabolic steroids or testosterone
• glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of = 50 mg)
• systemic hormone replacement therapy (HRT) (subjects stable on HRT for more than 3 months prior is permitted)
• calcitonin
• other bone active drugs including anti-convulsants (except
benzodiazepines) and heparin
• cathepsin K inhibitor
• anti-sclerostin antibody
• chronic systemic ketoconazole, androgens, adrenocorticotrophic
hormone, cinacalcet, aluminum, lithium, protease inhibitors,
gonadotropin- releasing hormone agonists
- Evidence of history of any of the following:
• hyperthyroidism (stable on antithyroid therapy is allowed)
• hypothyroidism (stable on thyroid replacement therapy is allowed)
• hypo- or hyperparathyroidism
• hypo- or hypercalcemia based on the central laboratory reference ranges
• known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
• osteomalacia (chart review)
• osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease
• recent tooth extraction (within 6 months of screening visit)
• Paget disease of bone (subject report or chart review)
• other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
History of any solid organ or bone marrow transplant
- Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
- Contraindicated or poorly tolerant of denosumab therapy; contraindications include
• hypocalcemia
• hypersensitivity to drug or any component of the drug
- Contraindicated or poorly tolerant of zoledronic acid therapy;
contraindications include the following:
• hypocalcemia
• subjects with creatinine clearance of <35 mL/min and in those with evidence of acute renal impairment (calculated using Cockcroft Gault equation)
• hypersensitivity to any component of zoledronic acid solution
- Known intolerance to calcium or vitamin D supplements
- For women of child bearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication
- Self-reported alcohol or drug abuse within 12 months prior to screening
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigation
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Post Menospausal Osteoporosis MedDRA version: 16.1
Level: PT
Classification code 10031282
Term: Osteoporosis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
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Intervention(s)
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Trade Name: Prolia Product Name: Denosumab Product Code: AMG 162 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Other descriptive name: DENOSUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Trade Name: Zometa Product Name: Zoledronic acid Product Code: MO5BA08 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072-93-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: Compare the efficacy of administering denosumab (60 mg SC Q6M), with that of zoledronic acid (5 mg IV once yearly), on the following: • BMD by DXA of total hip at 12 months (non - inferiority) • BMD by DXA of lumbar spine at 12 months (superiority) • BMD by DXA of total hip at 12 months (superiority)
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Timepoint(s) of evaluation of this end point: Month 12
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Primary end point(s): Primary Endpoint: • percent change from baseline in lumbar spine BMD at month 12 (non-inferiority)
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Main Objective: The primary objective of this study is to evaluate if the effect of administering denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of zoledronic acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months.
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Secondary Outcome(s)
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Secondary end point(s): Secondary Endpoints:
• percent change from baseline in total hip BMD at month 12 (non-inferiority)
• percent change from baseline in lumbar spine BMD at month 12 (superiority)
• percent change from baseline in total hip BMD at month 12 (superiority)
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Timepoint(s) of evaluation of this end point: Month 12
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Secondary ID(s)
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20110153
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2012-001821-28-DE
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Source(s) of Monetary Support
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Amgen Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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