Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP

Effect and Cost Comparation of Different Treatment Strategies for Osteoporotic Vertebral Fractures (OVF): Teriparatide Injection and Percutaneous Vertebroplasty (PVP)

This study aimed to compare teriparatide treatments and PVPs, focusing on its effects on life qualities and effect/coast ratio and evaluate which method is better for patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Osteoporosis, Postmenopausal; Vertebral Fracture
• Intervention / Treatment: Drug: Teriparatide; Procedure: PVP; Drug: Alendronate

Detailed Description

Osteoporosis and osteoporotic vertebral fracture (OVF)s are the common diseases that affect the qualities of senior people. The general treatments for OVFs including percutaneous vertebroplasty (PVP) operation and conservative treatments with pain killers. But with the widely used methods, the life quality of patients were still not satisfied. Teriparatide has been proven to increase bone qualities in patients with severe osteoporosis and reduced the fracture possibilities. The investigators' previous clinical observation found teriparatide could be applied to treat fresh OVFs.

90 participants who diagnosed fresh OVFS were included in the trial. After they received each of three kinds of interventions mentioned in this study, The investigators followed up all these cases. Once 30 cases goal reaches in a certain group, the data collection in that special will stop automatically. The quality of life, pain score and BMDs will be evaluated in certain time during the trial.

• Study Type: Observational
• Enrollment (Anticipated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

postmenopaual women with osteoporotic vertebral fractures, reveived treatments with teriparatide, PVP, teriparatide after PVP, or fosamax only.

Description

Inclusion Criteria:

• 1.postmenopausal women with osteoporotic fractures 2.treated with teriparatide 3.or treated with vertebroplasty 4.or treated with teriparatide after vertebroplasty 5.or treated with Fosamax 6. willing to anticipate the trial

Exclusion Criteria:

• Serious other illness or disease which effecting quality of life occurs later in treatment
• unwilling to anticipate the trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
teriparatide group; The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide	Drug: Teriparatide; subcutaneous injection of teriparatide(20 mg) once daily
PVP group plus alendronate; The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.	Procedure: PVP; With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously; Drug: Alendronate; Alendronate Sodium, oral, 70mg, once a week
teriparatide and PVP group; The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty	Drug: Teriparatide; subcutaneous injection of teriparatide(20 mg) once daily; Procedure: PVP; With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of the patients	The quality of life will be evaluated with SF-36 questionaire	Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain cause by the fracture	VAS score will be used to evaluate the pain caused by OVF	Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
Bone healing	Bone healing will be evaluated with MRI scanning	3 month after treatment
Bone mineral density	Bone mineral density will be evaluated with DEXA.	Change from pre treatment at 6 months, 1 year and 2 years post treatment

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: Dehong Yang, MD,PhD, NanFang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Osteoporosis; Osteoporosis, Postmenopausal; Spinal Fractures; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Alendronate; Teriparatide
• Other Study ID Numbers: NFEC-2018-067

Drug and device information, study documents

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