Prevention of bone loss Musculoskeletal Diseases Bone loss
Conditions
Interventions
Concerning the three arms of the study, there are two treatment groups, one receiving constant (one hour per day) and the other varying (one hour per day) small electrical nerve stimulation (interfere
Sponsors
RS Medical (USA)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed