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

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03133195

Collaborator

(none)

Enrollment

Location

Arms

57.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unstable Intertrochanteric Fracture	Drug: Teriparatide Drug: Placebo Dietary Supplement: Calcium supplement Dietary Supplement: Vitamin D	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

double blind, placebo-controlled

Primary Purpose:

Treatment

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)

Actual Study Start Date :

May 17, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teriparatide Teriparatide 20 μg subcutaneous once daily for 12 weeks	Drug: Teriparatide Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector) Other Names: r-Human parathyroid hormone Dietary Supplement: Calcium supplement 1000 mg/day of elemental calcium Dietary Supplement: Vitamin D 20,000 IU/week of vitamin D2
Placebo Comparator: Placebo Placebo subcutaneous once daily for 12 weeks	Drug: Placebo Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector) Dietary Supplement: Calcium supplement 1000 mg/day of elemental calcium Dietary Supplement: Vitamin D 20,000 IU/week of vitamin D2

Arm

Intervention/Treatment

Experimental: Teriparatide

Teriparatide 20 μg subcutaneous once daily for 12 weeks

Drug: Teriparatide

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

Other Names:

r-Human parathyroid hormone

Dietary Supplement: Calcium supplement

1000 mg/day of elemental calcium

Dietary Supplement: Vitamin D

20,000 IU/week of vitamin D2

Placebo Comparator: Placebo

Placebo subcutaneous once daily for 12 weeks

Drug: Placebo

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

Dietary Supplement: Calcium supplement

1000 mg/day of elemental calcium

Dietary Supplement: Vitamin D

20,000 IU/week of vitamin D2

Outcome Measures

Primary Outcome Measures

Time to healing assessed by radiographic evidence [from randomization, assessed up to 24 months]
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 [from randomization, assessed up to 24 months]
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 [from randomization, assessed up to 24 months]
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 [from randomization, assessed up to 24 months]
Walking ability (Independent walking, Assisted walking, Bedridden)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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