Back to results

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis (Confors)

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

teriparatide

teriparatide and raloxifene

teriparatide and alendronate

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring teriparatide, alendronate, raloxifene, bone mineral density

Eligibility Criteria

55 Years - 88 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Teriparatide

Teriparatide and Raloxifene

Teriparatide and Alendronate

Arm Description

18 months of daily 20 ug sc. teriparatide monotherapy (TPTD)

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01535027

First Posted

December 20, 2011

Last Updated

December 30, 2012

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01535027

Brief Title

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

Acronym

Confors

Official Title

Phase IV Study Teriparatide and Antiresorptive Combination Treatment Subsequent to 9 Months of Teriparatide Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

teriparatide, alendronate, raloxifene, bone mineral density

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teriparatide

Arm Type

Active Comparator

Arm Description

18 months of daily 20 ug sc. teriparatide monotherapy (TPTD)

Arm Title

Teriparatide and Raloxifene

Arm Type

Active Comparator

Arm Description

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

Arm Title

Teriparatide and Alendronate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

teriparatide

Other Intervention Name(s)

Forteo

Intervention Description

teriparatide 20 ug/day, sc.

Intervention Type

Drug

Intervention Name(s)

teriparatide and raloxifene

Other Intervention Name(s)

Forteo, Evista

Intervention Description

teriparatide 20 ug/day sc. raloxifene 60mg oral daily

Intervention Type

Drug

Intervention Name(s)

teriparatide and alendronate

Other Intervention Name(s)

Forteo, Fosamax

Intervention Description

teriparatide 20 ug/day sc. alendronate 70mg oral weekly

Primary Outcome Measure Information:

Title

Differences in changes of areal lumbar spine BMD between the three treatment groups

Description

Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups

Time Frame

Evaluation after 9, 12 and 18 months of TPTD

Secondary Outcome Measure Information:

Title

Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment

Description

Time Frame

Evaluation after 9, 12 and 18 months of TPTD treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Muschitz, M.D.

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1060

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

24619763

Citation

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.

Results Reference

derived

Links:

URL

http://www.bhs-wien.at/index_html?sc=10355

Description

Homepage of Medical Department II, Vienna (German)

Learn more about this trial

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

We'll reach out to this number within 24 hrs