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

NCT03133195 | Completed Phase 3

• 1 other identifier: ORTHCU-2017-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Unstable Intertrochanteric Fracture; Pertrochanteric Fracture of Femur, Closed

Keywords

Terriparatide, bone fracture healing, PFNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  from randomization, assessed up to 24 months

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

  from randomization, assessed up to 24 months

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

  from randomization, assessed up to 24 months

Study Arms (2)

Teriparatide

EXPERIMENTAL

Teriparatide 20 μg subcutaneous once daily for 12 weeks

Drug: Teriparatide; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous once daily for 12 weeks

Drug: Placebo; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D

Interventions

Teriparatide DRUG

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

Also known as: r-Human parathyroid hormone

Teriparatide

Placebo DRUG

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

Placebo

Calcium supplement DIETARY_SUPPLEMENT

1000 mg/day of elemental calcium

Placebo; Teriparatide

Vitamin D DIETARY_SUPPLEMENT

20,000 IU/week of vitamin D2

Placebo; Teriparatide

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

Faculty of Medicine Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

Teriparatide; Vitamin D

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Prof.Dr.Aree Tanavalee, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr., M.D.

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

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 28, 2017
• Study Start: May 17, 2017
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2023
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

TH (1)