- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01535027
Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis (Confors)
Phase IV Study Teriparatide and Antiresorptive Combination Treatment Subsequent to 9 Months of Teriparatide Monotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We prospectively randomize 125 postmenopausal women after 9 months of TPTD treatment into three different open-label groups for another 9 months: either alendronate (ALN, 70 mg/week), raloxifene (RAL, 60 mg/day) or no medication (TPTD mono) on top of ongoing TPTD treatment.
All subjects receive daily supplementation of 1000mg calcium and 800 IU vitamin D.
Serum level of intact amino terminal propeptide of type I procollagen (PINP) and type 1 collagen cross-linked C-telopeptide (CTX) as well as DXA measurement at the spine, total hip and femoral neck BMD are evaluated at TPTD treatment initiation, at baseline of randomization to antiresorptive therapy as well as at 3 and 9 months during the combination treatment.Volumetric BMD values will be also determined.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Vienna, Austria, 1060
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ambulatory postmenopausal women at least 55 years of age
- Patients with "unsatisfactory clinical response to previous antiresorptive therapy" according to the national reimbursement criteria of Austria (either new clinical or radiographic fragility fracture on ≥ 2 years and/or accelerated bone loss of ≥ 3.5%/year on antiresorptive treatment; discontinuation of oral antiresorptive treatment due to side-effects and substantial risk for osteoporotic fracture defined by a T-Score ≤ -2.5 or ≥ 2 clinical risk factors according to the FRAX™-algorithm)and consequently started with teriparatide treatment
- Patients treated with teriparatide (20 ug/day) currently and since 9 months for postmenopausal osteoporosis
- Lumbar spine, femoral neck, and total hip evaluable by dual energy x ray absorptiometry (DXA)
- Normal or clinically non-significant abnormal laboratory values (as defined by the investigator)
- Without language barrier, cooperative, expected to return for all follow-up procedures, and who give informed consent before entering the study and after being informed of the medications and procedures to be used in this study
Exclusion Criteria:
- History of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption
- History of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease
- History of nephrolithiasis or urolithiasis in the prior 2 years. Patients with any documented history of nephro- or uro-lithiasis must have had an appropriate imaging procedure within the prior 6 months, such as, an intravenous pyleogram (IVP), supine radiograph of the kidney ureter bladder, or renal ultrasound, which must document the absence of stones
- Abnormal thyroid function at any time in the prior 6 months. Patients with chronic hypothyreosis and adequate substitution therapy are permitted
- Active liver disease (liver enzymes more than three times the upper limit of normal) or clinical jaundice
- Significantly impaired renal function. This is defined as serum creatinine >1.8 mg/dL
- Treatment with bone active agent other than teriparatide in the prior 9 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Teriparatide
18 months of daily 20 ug sc.
teriparatide monotherapy (TPTD)
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teriparatide 20 ug/day, sc.
Other Names:
|
Active Comparator: Teriparatide and Raloxifene
9 months teriparatide 20 ug/day sc.
monotherapy (TPTD) continued by combination therapy of raloxifene 60 mg/day orally(RAL)and TPTD for another 9 months
|
teriparatide 20 ug/day sc.
raloxifene 60mg oral daily
Other Names:
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Active Comparator: Teriparatide and Alendronate
9 months teriparatide monotherapy 20 ug/day sc.(TPTD) continued by combination therapy of alendronate 70 mg/week orally(ALN)and TPTD for another 9 months
|
teriparatide 20 ug/day sc.
alendronate 70mg oral weekly
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in changes of areal lumbar spine BMD between the three treatment groups
Time Frame: Evaluation after 9, 12 and 18 months of TPTD
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Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups
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Evaluation after 9, 12 and 18 months of TPTD
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment
Time Frame: Evaluation after 9, 12 and 18 months of TPTD treatment
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Secondary objectives
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Evaluation after 9, 12 and 18 months of TPTD treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Muschitz, M.D., Medical University of Vienna
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Alendronate
- Raloxifene Hydrochloride
- Teriparatide
Other Study ID Numbers
- Vinforce-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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