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Strontium Ranelate and KOA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Strontium Ranelate
physiotherapy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged ≥ 40 years with symptoms of knee osteoarthritis

Exclusion Criteria:

rheumatoid arthritis, spondyloarthropathy

Sites / Locations

  • Mansoura Uninersity Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

strontium ranelate

physiotherapy

Arm Description

included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years,

included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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

Full Information

First Posted
May 2, 2019
Last Updated
May 3, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03937518
Brief Title
Strontium Ranelate and KOA
Official Title
Strontium Ranelate as New Modality in Treatment of Primary Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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 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: I. 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. D) 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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strontium ranelate
Arm Type
Other
Arm Description
included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years,
Arm Title
physiotherapy
Arm Type
Other
Arm Description
included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years
Intervention Type
Drug
Intervention Name(s)
Strontium Ranelate
Intervention Description
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 (
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
change of pain from base line
Description
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)
Time Frame
immediately before intervention,3 monthes after intervention,6 monthes after intervention
Secondary Outcome Measure Information:
Title
change of function from base line
Description
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.
Time Frame
immediately before intervention,3 monthes after intervention,6 monthes after intervention
Title
change of MRI findings from base line
Description
Assessment of knee joint by using semi-quantitative MRI by (MOAKS) MRI Osteoarthritis knee score which is performed
Time Frame
immediately before intervention and 6 monthes after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥ 40 years with symptoms of knee osteoarthritis Exclusion Criteria: rheumatoid arthritis, spondyloarthropathy
Facility Information:
Facility Name
Mansoura Uninersity Faculty of Medicine
City
Mansoura
State/Province
Dakahlia Provence
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Strontium Ranelate and KOA

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