OsteoporosisPhase 4ConforsNCT01535027
Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis
A Phase 4 study testing teriparatide, teriparatide and raloxifene and teriparatide and alendronate in people with Osteoporosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Read more about this study
- Who is it for?
- Ages 55 to 88 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- teriparatide, teriparatide and raloxifene and teriparatide and alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2006to Dec 2012
- Phase
- Phase 4
- 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 55 to 88 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study Teriparatide and Antiresorptive Combination Treatment Subsequent to 9 Months of Teriparatide Monotherapy
Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- teriparatide, teriparatide and raloxifene, teriparatide and alendronate
- Keywords
- teriparatide, alendronate, raloxifene, bone mineral density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teriparatideDrug
Also called Forteo
teriparatide 20 ug/day, sc.
teriparatide and raloxifeneDrug
Also called Forteo, Evista
teriparatide 20 ug/day sc. raloxifene 60mg oral daily
teriparatide and alendronateDrug
Also called Forteo, Fosamax
teriparatide 20 ug/day sc. alendronate 70mg oral weekly
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Active comparator | 18 months of daily 20 ug sc. teriparatide monotherapy (TPTD) Receives: Drug: teriparatide |
| Teriparatide and Raloxifene | Active comparator | 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 Receives: Drug: teriparatide and raloxifene |
| Teriparatide and Alendronate | Active comparator | 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 Receives: Drug: teriparatide and alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in changes of areal lumbar spine BMD between the three treatment groups
Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups
Measured: Evaluation after 9, 12 and 18 months of TPTD
Secondary outcomes (1)
Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment
Secondary objectives
- Differences in change of biochemical markers of bone turnover (serum CTX and serum PINP) between treatment groups
- Differences in change of the additional DXA results in the hip scan (neck, upper neck, nape, Wards, Troch, shaft, total hip [g/cm²]) of patients between treatment groups
- To investigate the volumetric changes of vertebral and hip BMD by quantitative computertomography of patients between treatment groups
- To investigate safety and tolerability of the treatments
Measured: Evaluation after 9, 12 and 18 months of TPTD treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMar 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Muschitz, Medical University of Vienna
- Investigators
- Christian Muschitz, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535027
- Sponsor's protocol ID
- Vinforce-003
- Acronym
- Confors
- Status last verified
- Dec 2012
- First submitted
- 20 Dec 2011
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Muschitz C, Kocijan R, Fahrleitner-Pammer A, Pavo I, Haschka J, Schima W, Kapiotis S, Resch H. Overlapping and continued alendronate or raloxifene administration in patients on teriparatide: effects on areal and volumetric bone mineral density--the CONFORS Study. J Bone Miner Res. 2014 Aug;29(8):1777-85. doi: 10.1002/jbmr.2216.
PubMed 24619763
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study Teriparatide and Antiresorptive Combination Treatment Subsequent to 9 Months of Teriparatide Monotherapy
- ClinicalTrials.gov ID
- NCT01535027
- Acronym / sponsor ID
- Confors / Vinforce-003
- Conditions
- Osteoporosis
- Keywords
- teriparatide, alendronate, raloxifene, bone mineral density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Active comparator | Drug: teriparatide18 months of daily 20 ug sc. teriparatide monotherapy (TPTD) |
| Teriparatide and Raloxifene | Active comparator | Drug: teriparatide and raloxifene9 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 and Alendronate | Active comparator | Drug: teriparatide and alendronate9 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 |
Who may qualify
- Ages
- 55 to 88 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teriparatideAlso: Forteoteriparatide 20 ug/day, sc. | Drug | Teriparatide |
| teriparatide and raloxifeneAlso: Forteo, Evistateriparatide 20 ug/day sc. raloxifene 60mg oral daily | Drug | Teriparatide and Raloxifene |
| teriparatide and alendronateAlso: Forteo, Fosamaxteriparatide 20 ug/day sc. alendronate 70mg oral weekly | Drug | Teriparatide and Alendronate |
Primary outcome
Differences in changes of areal lumbar spine BMD between the three treatment groups
Time frame: Evaluation after 9, 12 and 18 months of TPTD
Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Derived from this study: PubMed 24619763Muschitz C, Kocijan R, Fahrleitner-Pammer A, Pavo I, Haschka J, Schima W, Kapiotis S, Resch H. Overlapping and continued alendronate or raloxifene administration in patients on teriparatide: effects on areal and volumetric bone mineral density--the CONFORS Study. J Bone Miner Res. 2014 Aug;29(8):1777-85. doi: 10.1002/jbmr.2216.
- Homepage of Medical Department II, Vienna (German)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Muschitz, M.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing teriparatide, teriparatide and raloxifene and teriparatide and alendronate in people with Osteoporosis, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 7 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 3 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 1 site in Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Differences in changes of areal lumbar spine BMD between the three treatment groups (time frame: Evaluation after 9, 12 and 18 months of TPTD). 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 NCT01535027, which also lists 1 linked publication.
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 3 Jan 2013.