NCT03692143

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
55mo left

Started Jan 2017

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2017Dec 2030

Study Start

First participant enrolled

January 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

October 2, 2018

Status Verified

July 1, 2018

Enrollment Period

8.2 years

First QC Date

September 19, 2018

Last Update Submit

September 28, 2018

Conditions

Osteoporosis, PostmenopausalVertebral FractureQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain cause by the fracture

    Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment

  • Bone healing

    3 month after treatment

  • Bone mineral density

    Change from pre treatment at 6 months, 1 year and 2 years post treatment

Study Arms (3)

teriparatide group

The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide

Drug: Teriparatide

PVP group plus alendronate

The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed.

Procedure: PVPDrug: Alendronate

teriparatide and PVP group

The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty

Drug: TeriparatideProcedure: PVP

Interventions

TeriparatideDRUG

subcutaneous injection of teriparatide(20 mg) once daily

teriparatide and PVP groupteriparatide group
PVPPROCEDURE

With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously

PVP group plus alendronateteriparatide and PVP group
AlendronateDRUG

Alendronate Sodium, oral, 70mg, once a week

PVP group plus alendronate

Eligibility Criteria

Age49 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Xie Y, Niu S, Ma Y, Liao Y, Zhu Y, Feng L, Zheng M, Yang D. Sequential anti-osteoporotic therapy with teriparatide and alendronate optimizes outcomes of percutaneous vertebroplasty in acute osteoporotic vertebral fractures: a 12-month prospective cohort study. BMC Musculoskelet Disord. 2025 Oct 29;26(1):1011. doi: 10.1186/s12891-025-09256-w.

    PMID: 41163205DERIVED

MeSH Terms

Conditions

Osteoporosis, PostmenopausalSpinal Fractures

Interventions

TeriparatideAlendronate

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Dehong Yang, MD,PhD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2018

First Posted

October 2, 2018

Study Start

January 1, 2017

Primary Completion

March 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

October 2, 2018

Record last verified: 2018-07