Knee OsteoarthritisNCT03937518
Strontium Ranelate and KOA
A study testing Strontium Ranelate and physiotherapy in people with Knee Osteoarthritis, run by Mansoura University at 1 site in Egypt.
Trial summary
The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups: Group 1: included 15 patients who received oral strontium ranelate and physiotherapy… Read more about this study
- Who is it for?
- Ages 50 to 62 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Strontium Ranelate and physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged ≥ 40 years with symptoms of knee osteoarthritis
Who cannot join
- rheumatoid arthritis, spondyloarthropathy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura Uninersity Faculty of Medicine
Al Mansurah, Dakahlia Provence, 050
About this study
Official title: Strontium Ranelate as New Modality in Treatment of Primary Knee Osteoarthritis
The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation
Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:
Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08. Inclusion
Read the detailed description
The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation
Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:
Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08.
InclusionAll patients were subjected to the following:
- History Taking :
- Personal History
- Name, age, sex, residence, marital status.
- Occupational status.
- Special habits e.g. smoking status (current/previous).
- Complaint: Taken in the patient's own words with special stress on disease duration.
- Present history: Onset, course and duration of disease. Analysis of complaint Pain: type of pain, site of pain, factors participating/alleviating pain. Swelling. Crepitus. Limitation of movement. Morning and inactivity stiffness, its duration and location. Other joints affected and its pattern of distribution. History of other systems affections: Neurological symptoms (muscle power and sensation of the lower limbs). Eye symptoms (redness, ulcers and blurred vision). Gastrointestinal tract (GIT) symptoms (diarrhea, heart burn and mucus in the stool). Urinary tract (UT) symptoms (dysuria and frequency). Skin affection (ulcers, erythema, papules and nodules).
- Past history:
History of surgical operation of knee.
HistoryAssessment of range of motion of the affected knee joint:
For any limitation in the range of motion of the knee joint.
- Special tests to assess ligaments and menisci:
Varus stress test for lateral collateral ligament. Valgus stress test for medial collateral ligament. Anterior drawer test for anterior cruciate ligament. Posterior drawer test for posterior cruciate ligament.
McMurry's test for menisci.Radiological investigations:
- Conditions
- Knee Osteoarthritis
- Being tested
- Strontium Ranelate, physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium RanelateDrug
Patients received strontium ranelate 2gm (one sachet daily with 50 ml water at bedtime at least 2 h after food), as the compliance of patient assessed by counting number of sachet that patient returns at every visit and safety is assessed by recording adverse effects as blood pressure and heart rate every visit and patients received physiotherapy program in the form of (US therapeutic acoustic radiation and exercise program) 3 times per week for 6 months.
Ultra sound (US):
Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (
physiotherapyOther
Ultra sound (US):
Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (Medserve, England) (Huang et al., 2001). Patients were positioned in a supine position with the affected knee flexed at 90° and the sound head was held stationary over the tibiofemoral joint medial to the patellar tendon to enhance energy penetration into the joint space (White et al., 2007).
Exercise program:
The subjects were treated with a group-exercise program composed of a range of motion of all lower limb and 45 min strengthening exercises with 5 min stretching exercises of lower limb muscles 3 times per week under the supervision of the same physiatrist (Fitzgerald and Oatis
| Study group | Role | What they receive |
|---|---|---|
| strontium ranelate | Other | included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, Receives: Drug: Strontium Ranelate; Other: physiotherapy |
| physiotherapy | Other | included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain from base line
VAS pain is a uni-dimensional tool used to measure pain intensity. It is a 10 cm horizontal line marked every 1 cm. Pain intensity ranges from 0 (no pain, the left end of the line) to 10 (worst possible pain, the right end of the line). The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: immediately before intervention,3 monthes after intervention,6 monthes after intervention
Secondary outcomes (2)
change of function from base line
Patients were assessed before treatment, at 3rd and 6th month after treatment using Western Ontario and McMaster Universities OA index (WOMAC). WOMAC is a self-administered composite questionnaire with three components to assess pain, knee stiffness and difficulty in the activity of daily living. Its first section contains 5 questions about pain, the second section includes 2 questions which assess knee stiffness and the last section is formed of 17 questions that measure the difficulty in the activity of daily living performance.
Measured: immediately before intervention,3 monthes after intervention,6 monthes after intervention
change of MRI findings from base line
Assessment of knee joint by using semi-quantitative MRI by (MOAKS) MRI Osteoarthritis knee score which is performed
Measured: immediately before intervention and 6 monthes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937518
- Sponsor's protocol ID
- MS 15.09.44
- Status last verified
- May 2018
- First submitted
- 2 May 2019
- Last updated
- 5 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strontium Ranelate as New Modality in Treatment of Primary Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03937518
- Acronym / sponsor ID
- MS 15.09.44
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 3 May 2019 (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.
The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation
Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:
Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08. Inclusion
Detailed description
The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation
Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:
Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08.
InclusionAll patients were subjected to the following:
- History Taking :
- Personal History
- Name, age, sex, residence, marital status.
- Occupational status.
- Special habits e.g. smoking status (current/previous).
- Complaint: Taken in the patient's own words with special stress on disease duration.
- Present history: Onset, course and duration of disease. Analysis of complaint Pain: type of pain, site of pain, factors participating/alleviating pain. Swelling. Crepitus. Limitation of movement. Morning and inactivity stiffness, its duration and location. Other joints affected and its pattern of distribution. History of other systems affections: Neurological symptoms (muscle power and sensation of the lower limbs). Eye symptoms (redness, ulcers and blurred vision). Gastrointestinal tract (GIT) symptoms (diarrhea, heart burn and mucus in the stool). Urinary tract (UT) symptoms (dysuria and frequency). Skin affection (ulcers, erythema, papules and nodules).
- Past history:
History of surgical operation of knee.
HistoryAssessment of range of motion of the affected knee joint:
For any limitation in the range of motion of the knee joint.
- Special tests to assess ligaments and menisci:
Varus stress test for lateral collateral ligament. Valgus stress test for medial collateral ligament. Anterior drawer test for anterior cruciate ligament. Posterior drawer test for posterior cruciate ligament.
McMurry's test for menisci.Radiological investigations:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strontium ranelate | Other | Drug: Strontium Ranelate, Other: physiotherapyincluded 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, |
| physiotherapy | Other | Other: physiotherapyincluded 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years |
Who may qualify
- Ages
- 50 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged ≥ 40 years with symptoms of knee osteoarthritis
Key exclusion criteria (1 listed)
- rheumatoid arthritis, spondyloarthropathy
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 |
|---|---|---|
| Strontium RanelatePatients received strontium ranelate 2gm (one sachet daily with 50 ml water at bedtime at least 2 h after food), as the compliance of patient assessed by counting number of sachet that patient returns at every visit and safety is assessed by recording adverse effects as blood pressure and heart rate every visit and patients received physiotherapy program in the form of (US therapeutic acoustic radiation and exercise program) 3 times per week for 6 months. Ultra sound (US): Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min ( | Drug | strontium ranelate |
| physiotherapyUltra sound (US): Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (Medserve, England) (Huang et al., 2001). Patients were positioned in a supine position with the affected knee flexed at 90° and the sound head was held stationary over the tibiofemoral joint medial to the patellar tendon to enhance energy penetration into the joint space (White et al., 2007). Exercise program: The subjects were treated with a group-exercise program composed of a range of motion of all lower limb and 45 min strengthening exercises with 5 min stretching exercises of lower limb muscles 3 times per week under the supervision of the same physiatrist (Fitzgerald and Oatis | Other | physiotherapy, strontium ranelate |
Primary outcome
change of pain from base line
Time frame: immediately before intervention,3 monthes after intervention,6 monthes after intervention
VAS pain is a uni-dimensional tool used to measure pain intensity. It is a 10 cm horizontal line marked every 1 cm. Pain intensity ranges from 0 (no pain, the left end of the line) to 10 (worst possible pain, the right end of the line). The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
2 secondary outcomes
change of function from base line
Time frame: immediately before intervention,3 monthes after intervention,6 monthes after intervention
change of MRI findings from base line
Time frame: immediately before intervention and 6 monthes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strontium Ranelate and physiotherapy in people with Knee Osteoarthritis, run by Mansoura University at 1 site in Egypt.
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 1 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of pain from base line (time frame: immediately before intervention,3 monthes after intervention,6 monthes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2020.