Randomised, single centre, single blind feasibility study to determine the safety and effectiveness of interferential stimulation when compared to standard of care for the maintenance of bone density in pre-menopausal women receiving a Gonadotropin-Releasing Hormone (GnRH) agonist
- Conditions
- Prevention of bone lossMusculoskeletal DiseasesBone loss
- Registration Number
- ISRCTN02464830
- Lead Sponsor
- RS Medical (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 30
1. Has provided informed and written consent to participate voluntarily in the study
2. Is a pre-menopausal woman between 18 and 46 years of age at the time of study entry
3. Has a normal T-score on Dual-energy X-ray Absorptiometry (DXA) evaluation of the hip and spine (T-score greater than or equal to -1 for the patient?s age group)
4. Is willing and eligible to take Zoladex® for six months
5. Is willing to follow non-hormonal contraceptive advice relating to GnRHa treatment if sexually active and of childbearing potential
1. Is hypersensitive or uncomfortable with receiving electrical stimulation treatments
2. Has or has had any form of cancer (a contraindication to electrical stimulation)
3. Uses a cardiac demand pacemaker (a contraindication to electrical stimulation)
4. Is affected by or has a history of bone disease, such as osteoarthritis, Paget?s disease, spondyloarthropathies or scoliosis
5. Has an unexplained abnormal uterine bleeding or endometrial carcinoma
6. Has pathological fractures or any fractures of the thoracolumbar spine
7. Has internal orthopaedic spinal fixation devices
8. Has a known history of collagen-vascular or auto-immune disease (e.g. systemic lupus erythematosis), bleeding abnormalities, immunodeficiency, chronic debilitating disease, or malignancy within the last five years
9. Is pregnant, or breastfeeding or intends to become pregnant in the next six months
10. Has a known hypersensitivity to Luteinising Hormone-Releasing Hormone (LHRH), LHRH agonist analogues or any of the components in Zoladex®
11. Has taken a GnRHa within the past two years
12. Has taken an androgen, calcitonin or bisphosphonate within the past six months
13. Has taken an oral oestrogen within the previous two months
14. Has taken systemic glucocorticoids for more than one month within the past year
15. Is currently taking anti-seizure drugs or pharmacological doses of cholecalciferol
16. Has endocrine disorders requiring therapy (except for type II diabetes or hypothyroidism)
17. Follows a medication regimen that has changed 14 days prior to enrolment (drugs interfering with bone metabolism are not permitted)
18. Has a history of analgesic or opioid abuse/addiction
19. Has participated in another clinical study involving an investigational device or drug within 30 days prior to enrolment
20. Is unable to attend all study visits or self-administer study treatments for a total of six months
21. Is unable to read or write in English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The principal research objective is to evaluate the safety of interferential stimulation when used by pre-menopausal women who are hypo-oestrogenic as a result of taking a GnRH agonist when compared to a control group (standard of care only). Safety will be assessed by the rate of adverse event reports.
- Secondary Outcome Measures
Name Time Method The secondary research objective is to assess the effectiveness of interferential stimulation, after six months of treatment, in reducing BMD loss in the lumbar spine as measured by Dual-energy X-ray Absorptiometry (DXA). Two treatment groups, one receiving constant and the other varying small electrical nerve stimulation (interferential stimulation) and the GnRH agonist Zoladex®, will be compared to a control group receiving standard of care only (Zoladex®). The endpoint is the difference in BMD between the baseline and study month six DXA scans in the three study groups.