Osteoarthritis of the ShoulderNCT00479687

SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

A study testing SUPARTZ® and Phosphate Buffered Saline in people with Osteoarthritis of the Shoulder, run by Bioventus LLC.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 35 years and older
Conditions the study is for: Osteoarthritis of the Shoulder
What is being tested?: SUPARTZ® and Phosphate Buffered Saline
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: No sites listed yet
Study dates: May 2007to Oct 2009
Phase: Interventional
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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Glenohumeral Osteoarthritis (OA) confirmed by radiograph
Limitation of shoulder motion in at least one direction
Retained active range of motion of at least 30% in all directions

Who cannot join

Full thickness rotator cuff tear or rotator cuff tendinopathy
Frozen shoulder
Female who is pregnant or lactating

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain

This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.

Read the detailed description

Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder

Conditions: Osteoarthritis of the Shoulder
Being tested: SUPARTZ®, Phosphate Buffered Saline
Keywords: Osteoarthritis, Shoulder, Hyaluronic Acid (HA)
Medical subject headings: Osteoarthritis

What participants receive

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

SUPARTZ®Device
Three Supartz injections over 2 weeks into the glenohumeral joint space.
Phosphate Buffered SalineDevice
Also called Saline
Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.

Study groups in NCT00479687
Study group	Role	What they receive
Supartz	Active comparator	SUPARTZ® 3 injections over 2 weeks Receives: Device: SUPARTZ®
Phosphate Buffered Saline	Placebo comparator	Phosphate Buffered Saline 3 injections over 2 weeks Receives: Device: Phosphate Buffered Saline

What is being measured

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

Visual Analogue Scale (VAS: 0-100) for Pain on Movement
Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be.
Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.)
Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26
Measured: Ph1: weeks 7 - 26

Timeline

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

May 2007Oct 2009

First posted28 May 2007 (estimated)
Study startMay 2007
Primary completionOct 2009
Study completionOct 2009

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 Osteoarthritis of the ShoulderStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00479687
Sponsor's protocol ID: SHO-0106
Status last verified: Apr 2021
First submitted: 24 May 2007
Last updated: 27 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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

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All Osteoarthritis of the Shoulder trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain
ClinicalTrials.gov ID: NCT00479687
Acronym / sponsor ID: SHO-0106
Conditions: Osteoarthritis of the Shoulder
Keywords: Osteoarthritis, Shoulder, Hyaluronic Acid (HA)
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Bioventus LLCIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 28 May 2007 (estimated)
Results: Posted 2 Apr 2021

Clinical summary

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

Detailed description

Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder

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
Supartz	Active comparator	Device: SUPARTZ®SUPARTZ® 3 injections over 2 weeks
Phosphate Buffered Saline	Placebo comparator	Device: Phosphate Buffered SalinePhosphate Buffered Saline 3 injections over 2 weeks

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Glenohumeral Osteoarthritis (OA) confirmed by radiograph
Limitation of shoulder motion in at least one direction
Retained active range of motion of at least 30% in all directions

Key exclusion criteria (3 listed)

Full thickness rotator cuff tear or rotator cuff tendinopathy
Frozen shoulder
Female who is pregnant or lactating

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
SUPARTZ®Three Supartz injections over 2 weeks into the glenohumeral joint space.	Device	Supartz
Phosphate Buffered SalineAlso: SalineThree phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.	Device	Phosphate Buffered Saline

Primary outcome

Visual Analogue Scale (VAS: 0-100) for Pain on Movement
Time frame: Ph1: weeks 7 - 26
Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ph1: Supartz (Double Blind)	150	125
Ph1: Phosphate Buffered Saline (Double Blind)	150	131
Ph2: Supartz (Open Label)	0	0

Primary outcome: Visual Analogue Scale (VAS: 0-100) for Pain on Movement

Time frame: Ph1: weeks 7 - 26. Least squares mean (Standard Error). Unit: units on a scale

Measure	Ph1: Supartz (Double Blind) n = 133	Ph1: Phosphate Buffered Saline (Double Blind) n = 130
Value	53.7665 (1.7513)	57.7659 (1.7569)

Ph1: Supartz (Double Blind) vs Ph1: Phosphate Buffered Saline (Double Blind): p = 0.0380, Mixed Models Analysis

Population analysed: Glenohumeral Osteoarthritis (GH-OA) Intention-to-Treat (ITT) population includes all randomized subjects who had no clinical diagnosis of concomitant pathologies in the trial shoulder

Adverse events

Time frame: 52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supartz (Double Blind)	11 of 150 (7.3%)	54 of 150 (36%)	Not reported
Phosphate Buffered Saline (Double Blind)	5 of 150 (3.3%)	56 of 150 (37.3%)	Not reported
Supartz (Open Label)	5 of 224 (2.2%)	21 of 224 (9.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis of the Shoulder

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Not yet recruitingObservational study
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Knee Osteoarthristis, Hip Osteoarthritis
Not yet recruiting
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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.

Scott Sledge, MD principal investigator

Northeast Orthopedics - Unlimited Research

Charles Birbara, MD principal investigator

Clinical Pharmacology Study Group

Questions about this trial

What is this clinical trial studying?

A study testing SUPARTZ® and Phosphate Buffered Saline in people with Osteoarthritis of the Shoulder, run by Bioventus LLC.

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 3 inclusion and 3 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 27 Apr 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2021). 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?

Visual Analogue Scale (VAS: 0-100) for Pain on Movement (time frame: Ph1: weeks 7 - 26). 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 NCT00479687.

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 27 Apr 2021.