OsteoporosisPhase 4NCT01267279

Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

A Phase 4 study testing Zoledronic acid in people with Osteoporosis, run by Spokane Joint Replacement Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Osteoporosis
What is being tested?: Zoledronic acid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: No sites listed yet
Study dates: Jan 2005to Dec 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Patients undergoing primary elective total hip replacement

Who cannot join

Osteoporosis (BMD ≤-2.5)
Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
Severe renal impairment
Use of any medications affecting BMD
Known sensitivity to bisphosphonates
Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods

About this study

Conditions: Osteoporosis
Being tested: Zoledronic acid, Placebo
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zoledronic acidDrug
Also called Reclast
Zoledronic acid per protocol
PlaceboOther
Placebo

Study groups in NCT01267279
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Other: Placebo
Zoledronic Acid	Experimental	Not described Receives: Drug: Zoledronic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Bone Mineral Density (BMD)
Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.
Measured: 2 years post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Dec 2014

First posted28 Dec 2010 (estimated)
Study startJan 2005
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01267279
Sponsor's protocol ID: SJRC-Reclast
Status last verified: Nov 2018
First submitted: 24 Dec 2010
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
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Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT01267279
Acronym / sponsor ID: SJRC-Reclast
Conditions: Osteoporosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Spokane Joint Replacement CenterUniversity, hospital or other
Study start: Jan 2005
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 28 Dec 2010 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Other: Placebo
Zoledronic Acid	Experimental	Drug: Zoledronic acid

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing primary elective total hip replacement

Key exclusion criteria (6 listed)

Osteoporosis (BMD ≤-2.5)
Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
Severe renal impairment
Use of any medications affecting BMD
Known sensitivity to bisphosphonates

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
Zoledronic acidAlso: ReclastZoledronic acid per protocol	Drug	Zoledronic Acid
PlaceboPlacebo	Other	Placebo

Primary outcome

Bone Mineral Density (BMD)
Time frame: 2 years post-operative
Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	24	22
Zoledronic Acid	27	21

Primary outcome: Bone Mineral Density (BMD)

Time frame: 2 years post-operative. Mean (Standard Deviation). Unit: Percent change

Measure	Placebo n = 22	Zoledronic Acid n = 21
Gruen Zone 1: 2 years	-3.97 (15.2)	14.30 (9.8)
Gruen Zone 7: 2 years	-27.3 (11.4)	-9.58 (12.4)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 24 (8.3%)	0 of 24 (0%)	0 of 24
Zoledronic Acid	3 of 27 (11.1%)	2 of 27 (7.4%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zoledronic acid in people with Osteoporosis, run by Spokane Joint Replacement Center.

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 6 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: finished, as of the sponsor's last update on 19 Dec 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Bone Mineral Density (BMD) (time frame: 2 years post-operative). 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 NCT01267279.

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 19 Dec 2018.