Postmenopausal OsteoporosisNCT05650437
Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women
A study testing Ultraviolet Radiation, Aerobic exercise and Vitamin D supplementation in people with Postmenopausal Osteoporosis, run by Cairo University at 1 site in Egypt.
Trial summary
70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two groups by randomization. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Ultraviolet Radiation, Aerobic exercise and Vitamin D supplementation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2022to 15 Dec 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women who did not engage in any recreational physical activity in the previous three months Low bone mineral density (BMD) at their spine and/or femoral neck met the inclusion criteria.
- They are in good health. body mass index (BMI) ranged from 25 to 30 kg/m2, ages ranged from 50 to 60
Who cannot join
- mental, neurological, Vestibular, cardiovascular, metabolic disease, musculoskeletal disorders with lower limb deformity, visual or hearing impairment undergone hormone replacement therapy. any medication that affected their balance or photosensitizing medications like aspirin, tetracycline, and Chlorothiazide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women: A Randomized Controlled Study
70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two groups by randomization. 35 postmenopausal women in Group (A) will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months. For three months, group (B), which consists of 35 postmenopausal women, will undergo daily aerobic exercise and vitamin D supplementation (800 IU) only.
The amount of serum 25-hydroxyvitamin D was measured using ELISA kits, bone mineral density of lumber spine was measured by dual energy X-ray absorptiometry (DEXA), and the torque of knee flexors and extensors was evaluated using the Biodex System 3 isokinetic dynamometer,
Read the detailed description
Group (A): This group covers a sum of 35 postmenopausal women who underwent three weekly sessions of UV light therapy in addition to daily vitamin D supplements of 800 IU.
Ultraviolet therapy device It was an ultraviolet arc lamp made of a low-pressure mercury discharge tube with an internal phosphor coating. The chemical makeup of the phosphor utilized determined the specific wavelength and output of each light (mixtures of phosphates, borates, and silicates). This produces a sizable amount of UVA and UVB but none of UVC. The spectrum of the radiation: is 280-320 nm. Postmenopausal women in the group received treatment with quartz of the type 4004/2n- Verret (A).
Using dose-response assessment, which is graded according to the individual's erythema response and is classified as E1, Second-degree erythema (E2), Third-degree erythema (E3), and Fourth-degree erythema, the physical therapist determined the postmenopausal woman's sensitivity to UV before applying UV (E4).
The physical therapist instructed each case to wear safety glasses (goggles) to protect her eyes from UV, and treatment duration was calculated as a percentage of the MED of UV. The woman was then instructed to take off all of her clothes and wash her abdomen. After describing the steps to the woman and requesting that she avoid looking at the bulb due to the risk of eye damage. The therapist cut three holes, each measuring 2 by 2 cm, into a piece of cardboard that was about 4 by 20 cm in size.
Subsequently, the region around the cardboard was covered with a cloth to prevent the skin nearby from being exposed to radiation by placing the cardboard on the abdomen. The lamp was turned on and positioned 70 cm away and perpendicular to the abdominal region. Before turning toward the woman, the arc lamp needed five to ten minutes to warm up and attain maximum power. The UV beam was pointed straight at the abdomen region after the lamp had achieved maximum power, which activated the timer. The three holes were exposed to UV light for 30 seconds at a time, after which two holes were covered and one was left unattended for the following 30 seconds.
The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30 seconds by this protocol. Then, instruct the woman to document the region's reaction for 24 hours after exposure. The area that experienced minor skin reddening within eight hours and faded within twenty-four hours was given MED treatment. The minimum erythemal dose (MED) or E1 was the desired dose in this study.
Following the determination of the MED for each woman, the UV session was conducted as follows: To maximize exposure of the portion being treated and prevent unnecessary exposure of other parts, the postmenopausal lady was directed to remove clothing from the lower abdomen and lie in a supine position.
As for the rest of the body, which did not require exposure, it was covered. Goggles are necessary to shield the eyes from exposure. After that, the ultraviolet Arc lamp was adjusted so that it is positioned approximately 70 cm above the lower abdominal region in a perpendicular position. By the MED for each lady that was spotted, the lamp was switched on and the timer was changed.
The lamp was turned off and moved away from the postmenopausal woman by the end of the therapy period. Any noticeable reaction to the therapy was recorded within the three treatment sessions per week which were administered for a total of three months.
Aerobic exercise The postmenopausal women in groups (A and B) exercised on the treadmill; women should always warm up before beginning exercise and stop if they experience pain or shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and 20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that the circulatory system can support during physical exercise is MHR=220. Three sessions a week for three months, followed by a five-minute cool-down [10].
Vitamin D supplementation Throughout three months, vitamin D supplements (800 IU) were given to all postmenopausal women in both groups (A\&B).
The Group (B): This group comprises of 17 postmenopausal women who completed 3 months of daily aerobic exercise and vitamin D supplementation (800 IU).
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Ultraviolet Radiation, Aerobic exercise, Vitamin D supplementation
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet RadiationDevice
The therapist cut three holes, each measuring 2 by 2 cm, into a piece of cardboard that was about 4 by 20 cm in size.The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30 seconds
Aerobic exerciseBehavioural
The postmenopausal women in groups (A and B) exercised on the treadmill; women should always warm up before beginning exercise and stop if they experience pain or shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and 20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that the circulatory system can support during physical exercise is MHR=220. Three sessions a week for three months, followed by a five-minute cool-down
Vitamin D supplementationDietary supplement
Throughout three months, vitamin D supplements (800 IU) will be given to all postmenopausal women in both groups (A\&B)
| Study group | Role | What they receive |
|---|---|---|
| Ultraviolet therapy group | Active comparator | 35 women will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months Receives: Device: Ultraviolet Radiation; Behavioral: Aerobic exercise; Dietary Supplement: Vitamin D supplementation |
| Non Ultraviolet therapy group | Active comparator | 35 women will undergo three weekly sessions of routine aerobic activity and vitamin D supplements (800 IU) daily for three months Receives: Behavioral: Aerobic exercise; Dietary Supplement: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-score of mineral density of lumber spine
measured by dual energy X-ray absorptiometry
Measured: 3 months from treatment
Peak Torque of knee flexors and extensors
The isokinetic dynamometer for the Biodex System 3, Biodex Medical System, Shirley, New York, USA, was recommended to be used in the current study [11]. It was adopted in the study to evaluate the muscular strength of the knee flexors and extensors in all postmenopausal women in both groups
Measured: 3 months from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start30 Dec 2022
- Primary completion13 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed M Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650437
- Sponsor's protocol ID
- 66
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultraviolet Radiation on Bone Density and Muscle Strength in Postmenopausal Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05650437
- Acronym / sponsor ID
- 66
- Conditions
- Postmenopausal Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 14 Dec 2022 (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.
70 postmenopausal women, aged 50 to 60, who are vitamin D deficient and diagnosed with osteoporosis or osteopenia with T score of DEXA of lumbar spine (L1 to L4) was less than or equal -1 and their body mass index between 25 and 30 kg/m2. They will be divided into two groups by randomization. 35 postmenopausal women in Group (A) will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months. For three months, group (B), which consists of 35 postmenopausal women, will undergo daily aerobic exercise and vitamin D supplementation (800 IU) only.
The amount of serum 25-hydroxyvitamin D was measured using ELISA kits, bone mineral density of lumber spine was measured by dual energy X-ray absorptiometry (DEXA), and the torque of knee flexors and extensors was evaluated using the Biodex System 3 isokinetic dynamometer,
Detailed description
Group (A): This group covers a sum of 35 postmenopausal women who underwent three weekly sessions of UV light therapy in addition to daily vitamin D supplements of 800 IU.
Ultraviolet therapy device It was an ultraviolet arc lamp made of a low-pressure mercury discharge tube with an internal phosphor coating. The chemical makeup of the phosphor utilized determined the specific wavelength and output of each light (mixtures of phosphates, borates, and silicates). This produces a sizable amount of UVA and UVB but none of UVC. The spectrum of the radiation: is 280-320 nm. Postmenopausal women in the group received treatment with quartz of the type 4004/2n- Verret (A).
Using dose-response assessment, which is graded according to the individual's erythema response and is classified as E1, Second-degree erythema (E2), Third-degree erythema (E3), and Fourth-degree erythema, the physical therapist determined the postmenopausal woman's sensitivity to UV before applying UV (E4).
The physical therapist instructed each case to wear safety glasses (goggles) to protect her eyes from UV, and treatment duration was calculated as a percentage of the MED of UV. The woman was then instructed to take off all of her clothes and wash her abdomen. After describing the steps to the woman and requesting that she avoid looking at the bulb due to the risk of eye damage. The therapist cut three holes, each measuring 2 by 2 cm, into a piece of cardboard that was about 4 by 20 cm in size.
Subsequently, the region around the cardboard was covered with a cloth to prevent the skin nearby from being exposed to radiation by placing the cardboard on the abdomen. The lamp was turned on and positioned 70 cm away and perpendicular to the abdominal region. Before turning toward the woman, the arc lamp needed five to ten minutes to warm up and attain maximum power. The UV beam was pointed straight at the abdomen region after the lamp had achieved maximum power, which activated the timer. The three holes were exposed to UV light for 30 seconds at a time, after which two holes were covered and one was left unattended for the following 30 seconds.
The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30 seconds by this protocol. Then, instruct the woman to document the region's reaction for 24 hours after exposure. The area that experienced minor skin reddening within eight hours and faded within twenty-four hours was given MED treatment. The minimum erythemal dose (MED) or E1 was the desired dose in this study.
Following the determination of the MED for each woman, the UV session was conducted as follows: To maximize exposure of the portion being treated and prevent unnecessary exposure of other parts, the postmenopausal lady was directed to remove clothing from the lower abdomen and lie in a supine position.
As for the rest of the body, which did not require exposure, it was covered. Goggles are necessary to shield the eyes from exposure. After that, the ultraviolet Arc lamp was adjusted so that it is positioned approximately 70 cm above the lower abdominal region in a perpendicular position. By the MED for each lady that was spotted, the lamp was switched on and the timer was changed.
The lamp was turned off and moved away from the postmenopausal woman by the end of the therapy period. Any noticeable reaction to the therapy was recorded within the three treatment sessions per week which were administered for a total of three months.
Aerobic exercise The postmenopausal women in groups (A and B) exercised on the treadmill; women should always warm up before beginning exercise and stop if they experience pain or shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and 20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that the circulatory system can support during physical exercise is MHR=220. Three sessions a week for three months, followed by a five-minute cool-down [10].
Vitamin D supplementation Throughout three months, vitamin D supplements (800 IU) were given to all postmenopausal women in both groups (A\&B).
The Group (B): This group comprises of 17 postmenopausal women who completed 3 months of daily aerobic exercise and vitamin D supplementation (800 IU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultraviolet therapy group | Active comparator | Device: Ultraviolet Radiation, Behavioral: Aerobic exercise, Dietary Supplement: Vitamin D supplementation35 women will undergo three weekly sessions of UV therapy in addition to routine aerobic activity and vitamin D supplements (800 IU) daily for three months |
| Non Ultraviolet therapy group | Active comparator | Behavioral: Aerobic exercise, Dietary Supplement: Vitamin D supplementation35 women will undergo three weekly sessions of routine aerobic activity and vitamin D supplements (800 IU) daily for three months |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women who did not engage in any recreational physical activity in the previous three months Low bone mineral density (BMD) at their spine and/or femoral neck met the inclusion criteria.
- They are in good health. body mass index (BMI) ranged from 25 to 30 kg/m2, ages ranged from 50 to 60
Key exclusion criteria (1 listed)
- mental, neurological, Vestibular, cardiovascular, metabolic disease, musculoskeletal disorders with lower limb deformity, visual or hearing impairment undergone hormone replacement therapy. any medication that affected their balance or photosensitizing medications like aspirin, tetracycline, and Chlorothiazide
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 |
|---|---|---|
| Ultraviolet RadiationThe therapist cut three holes, each measuring 2 by 2 cm, into a piece of cardboard that was about 4 by 20 cm in size.The first hole was exposed for 90 seconds, the second for 60 seconds, and the third for 30 seconds | Device | Ultraviolet therapy group |
| Aerobic exerciseThe postmenopausal women in groups (A and B) exercised on the treadmill; women should always warm up before beginning exercise and stop if they experience pain or shortness of breath. Each session lasted 30 minutes and included 5 minutes of warming up and 20 minutes of walking at 60% of their maximum heart rate (MHR). The maximum heart rate that the circulatory system can support during physical exercise is MHR=220. Three sessions a week for three months, followed by a five-minute cool-down | Behavioural | Non Ultraviolet therapy group, Ultraviolet therapy group |
| Vitamin D supplementationThroughout three months, vitamin D supplements (800 IU) will be given to all postmenopausal women in both groups (A\&B) | Dietary supplement | Non Ultraviolet therapy group, Ultraviolet therapy group |
Primary outcome
T-score of mineral density of lumber spine
Time frame: 3 months from treatment
measured by dual energy X-ray absorptiometry
Peak Torque of knee flexors and extensors
Time frame: 3 months from treatment
The isokinetic dynamometer for the Biodex System 3, Biodex Medical System, Shirley, New York, USA, was recommended to be used in the current study [11]. It was adopted in the study to evaluate the muscular strength of the knee flexors and extensors in all postmenopausal women in both groups
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 12 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Postmenopausal Osteoporosis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, 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.
Ahmed M Maged principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet Radiation, Aerobic exercise and Vitamin D supplementation in people with Postmenopausal Osteoporosis, run by Cairo 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 2 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 12 Jan 2024. 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?
T-score of mineral density of lumber spine (time frame: 3 months from treatment). The study lists 2 primary outcomes in all. 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 12 Jan 2024.