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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Unstable Intertrochanteric Fracture
• Intervention / Treatment: Drug: Teriparatide; Dietary supplement: Calcium supplement; Dietary supplement: Vitamin D; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Prof. Dr. Aree Tanavalee, M.D.; Phone Number: +662 5664212; Email: areetang@orthochula.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Faculty of Medicine Chulalongkorn University
    • Contact: Aree Tanavalee, MD.; Phone Number: +662 2564230; Email: aeyrx23@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known hypersentivity to teriparatide or any form of PTH or analogue
2. Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
3. Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
4. 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.
5. Pre-existing of hypercalcemia (total serum calcium >10.5 mg/dL or 2.6 mmol/L)
6. Abnormally elevated serum intact parathyroid hormone at screening (serum PTH > 70 pg/mL)
7. Severe vitamin D deficiency (25-hydroxyvitamin D < 12 ng/mL)
8. Unexplained elevations of alkaline phosphatase (ALP > 120 UL)
9. Severe renal impairment (CrCL < 30 mL/min)
10. Current treatment with digoxin and necessary to continue use during the study
11. 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)
12. 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.
13. Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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	Dietary supplement: Calcium supplement; 1000 mg/day of elemental calcium; Dietary supplement: Vitamin D; 20,000 IU/week of vitamin D2; Drug: Placebo; Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from randomization, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	from randomization, assessed up to 24 months
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)	from randomization, assessed up to 24 months
Clinical evidence of healing assessed by walking ability as one of functional outcomes	Walking ability (Independent walking, Assisted walking, Bedridden)	from randomization, assessed up to 24 months

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital
• Investigators: Principal Investigator: Prof.Dr.Aree Tanavalee, M.D., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Terriparatide, bone fracture healing, PFNA
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Teriparatide; Parathyroid Hormone
• Other Study ID Numbers: ORTHCU-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No