Osteoporosis, PostmenopausalNCT03692143
Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP
An observational study of Osteoporosis, Postmenopausal and Vertebral Fracture, run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 99 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Vertebral Fracture, Quality of Life
- What is being tested?
- Teriparatide, PVP and Alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: postmenopaual women with osteoporotic vertebral fractures, reveived treatments with teriparatide, PVP, teriparatide after PVP, or fosamax only.
Who may be able to join
- 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
Who cannot join
- Serious other illness or disease which effecting quality of life occurs later in treatment
- unwilling to anticipate the trial
About this study
Official title: 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.
Read the 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.
- Being tested
- Teriparatide, PVP, Alendronate
- Medical subject headings
- Osteoporosis, Postmenopausal, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
subcutaneous injection of teriparatide(20 mg) once daily
PVPProcedure or surgery
With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously
AlendronateDrug
Alendronate Sodium, oral, 70mg, once a week
| Study group | Role | What they receive |
|---|---|---|
| teriparatide group | The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide Receives: Drug: Teriparatide | |
| PVP group plus alendronate | The group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed. Receives: Procedure: PVP; Drug: Alendronate | |
| teriparatide and PVP group | The group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty Receives: Drug: Teriparatide; Procedure: PVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of the patients
The quality of life will be evaluated with SF-36 questionaire
Measured: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
Secondary outcomes (3)
Pain cause by the fracture
VAS score will be used to evaluate the pain caused by OVF
Measured: 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
Measured: 3 month after treatment
Bone mineral density
Bone mineral density will be evaluated with DEXA.
Measured: Change from pre treatment at 6 months, 1 year and 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Jan 2017
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dehong Yang, MD,PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692143
- Sponsor's protocol ID
- NFEC-2018-067
- Status last verified
- Jul 2018
- First submitted
- 19 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 41163205
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Cost Comparation of Different Treatment Strategies for Osteoporotic Vertebral Fractures (OVF): Teriparatide Injection and Percutaneous Vertebroplasty (PVP)
- ClinicalTrials.gov ID
- NCT03692143
- Acronym / sponsor ID
- NFEC-2018-067
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| teriparatide group | – | Drug: TeriparatideThe group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide |
| PVP group plus alendronate | – | Procedure: PVP, Drug: AlendronateThe group of postmenopausal women who diagnosis with osteoporotic fractures treated with vertebroplasty. Then alendronate was prescribed. |
| teriparatide and PVP group | – | Drug: Teriparatide, Procedure: PVPThe group of postmenopausal women who diagnosis with osteoporotic fractures treated with teriparatide after vertebroplasty |
Who may qualify
- Ages
- 49 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopaual women with osteoporotic vertebral fractures, reveived treatments with teriparatide, PVP, teriparatide after PVP, or fosamax only.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Serious other illness or disease which effecting quality of life occurs later in treatment
- unwilling to anticipate the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teriparatidesubcutaneous injection of teriparatide(20 mg) once daily | Drug | teriparatide and PVP group, teriparatide group |
| PVPWith local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously | Procedure or surgery | PVP group plus alendronate, teriparatide and PVP group |
| AlendronateAlendronate Sodium, oral, 70mg, once a week | Drug | PVP group plus alendronate |
Primary outcome
Quality of life of the patients
Time frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
The quality of life will be evaluated with SF-36 questionaire
3 secondary outcomes
Pain cause by the fracture
Time frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment
Bone healing
Time frame: 3 month after treatment
Bone mineral density
Time frame: Change from pre treatment at 6 months, 1 year and 2 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 41163205Xie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dehong Yang, MD,PhD principal investigator
Nanfang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal and Vertebral Fracture, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of the patients (time frame: Change from pre treatment at 3 months, 6 months, 1 year and 2 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.