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The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

Primary Purpose

Unstable Intertrochanteric Fracture

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Teriparatide

Placebo

Calcium supplement

Vitamin D

About this trial

This is an interventional treatment trial for Unstable Intertrochanteric Fracture focused on measuring Terriparatide, bone fracture healing, PFNA

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patient, age ≥ 50 years at the time of screening
Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
Treated by proximal femoral nail antirotation (PFNA)

Exclusion Criteria:

Known hypersentivity to teriparatide or any form of PTH or analogue
Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
History of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study.
Pre-existing of hypercalcemia (total serum calcium >10.5 mg/dL or 2.6 mmol/L)
Abnormally elevated serum intact parathyroid hormone at screening (serum PTH > 70 pg/mL)
Severe vitamin D deficiency (25-hydroxyvitamin D < 12 ng/mL)
Unexplained elevations of alkaline phosphatase (ALP > 120 UL)
Severe renal impairment (CrCL < 30 mL/min)
Current treatment with digoxin and necessary to continue use during the study
Concurrent treatment with oral bisphosphonates, selective estrogen receptor modulator (SERMs), calcitonin, estrogen (oral, transdermal, or injection), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. (Previous treatment is allowed but must be discontinued at screening)
Previous treatment with strontium ranelate for any duration, intravenous bisphophonates within 12 months prior to the screening date, and/or denosumab within 6 months prior to the screening.
Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs

Sites / Locations

Faculty of Medicine Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Teriparatide

Placebo

Arm Description

Teriparatide 20 μg subcutaneous once daily for 12 weeks

Placebo subcutaneous once daily for 12 weeks

Outcomes

Primary Outcome Measures

Time to healing assessed by radiographic evidence

Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices)

Secondary Outcome Measures

Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes

Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, <70 poor)

Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes

Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing)

Clinical evidence of healing assessed by walking ability as one of functional outcomes

Walking ability (Independent walking, Assisted walking, Bedridden)

Full Information

NCT ID

NCT03133195

First Posted

April 21, 2017

Last Updated

September 6, 2020

Sponsor

King Chulalongkorn Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03133195

Brief Title

The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

Official Title

A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With Proximal Femoral Nail Antirotation (PFNA)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 17, 2017 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Chulalongkorn Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.

Detailed Description

Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks. All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2. Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.

6. Conditions and Keywords

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

Unstable Intertrochanteric Fracture

Keywords

Terriparatide, bone fracture healing, PFNA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The patients will be randomized in 1:1 ratio to receive Teriparatide or placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double blind, placebo-controlled

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Teriparatide

Arm Type

Experimental

Arm Description

Teriparatide 20 μg subcutaneous once daily for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneous once daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Teriparatide

Other Intervention Name(s)

r-Human parathyroid hormone

Intervention Description

Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium supplement

Intervention Description

1000 mg/day of elemental calcium

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Intervention Description

20,000 IU/week of vitamin D2

Primary Outcome Measure Information:

Title

Time to healing assessed by radiographic evidence

Description

Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices)

Time Frame

from randomization, assessed up to 24 months

Secondary Outcome Measure Information:

Title

Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes

Description

Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, <70 poor)

Time Frame

from randomization, assessed up to 24 months

Title

Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes

Description

Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing)

Time Frame

from randomization, assessed up to 24 months

Title

Clinical evidence of healing assessed by walking ability as one of functional outcomes

Description

Walking ability (Independent walking, Assisted walking, Bedridden)

Time Frame

from randomization, assessed up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patient, age ≥ 50 years at the time of screening Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3) Treated by proximal femoral nail antirotation (PFNA) Exclusion Criteria: Known hypersentivity to teriparatide or any form of PTH or analogue Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone) Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation) History of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study. Pre-existing of hypercalcemia (total serum calcium >10.5 mg/dL or 2.6 mmol/L) Abnormally elevated serum intact parathyroid hormone at screening (serum PTH > 70 pg/mL) Severe vitamin D deficiency (25-hydroxyvitamin D < 12 ng/mL) Unexplained elevations of alkaline phosphatase (ALP > 120 UL) Severe renal impairment (CrCL < 30 mL/min) Current treatment with digoxin and necessary to continue use during the study Concurrent treatment with oral bisphosphonates, selective estrogen receptor modulator (SERMs), calcitonin, estrogen (oral, transdermal, or injection), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. (Previous treatment is allowed but must be discontinued at screening) Previous treatment with strontium ranelate for any duration, intravenous bisphophonates within 12 months prior to the screening date, and/or denosumab within 6 months prior to the screening. Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Prof. Dr. Aree Tanavalee, M.D.

Phone

+662 5664212

areetang@orthochula.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof.Dr.Aree Tanavalee, M.D.

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aree Tanavalee, MD.

Phone

+662 2564230

aeyrx23@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

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