Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

NCT01535027 | Completed Phase 4 DMC

• 1 other identifier: Vinforce-003
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

teriparatide; alendronate; raloxifene; bone mineral density

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Evaluation after 9, 12 and 18 months of TPTD treatment

Study Arms (3)

Teriparatide

ACTIVE COMPARATOR

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

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

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

Drug: teriparatide and alendronate

Interventions

teriparatide DRUG

teriparatide 20 ug/day, sc.

Also known as: Forteo

Teriparatide

teriparatide and raloxifene DRUG

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

Also known as: Forteo, Evista

Teriparatide and Raloxifene

teriparatide and alendronate DRUG

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

Also known as: Forteo, Fosamax

Teriparatide and Alendronate

Eligibility Criteria

• Age: 55 Years - 88 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1060, Austria

Location

Related Publications (1)

• 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.

  PMID: 24619763 DERIVED

Related Links

• Homepage of Medical Department II, Vienna (German)

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide; Raloxifene Hydrochloride; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diphosphonates; Organophosphonates; Organophosphorus Compounds

Study Officials

• Christian Muschitz, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: February 17, 2012
• Study Start: March 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

AU (1)