E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hip osteoarthritis |
Lonkan nivelrikko |
|
E.1.1.1 | Medical condition in easily understood language |
Hip arthritis |
Lonkan kuluma |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020104 |
E.1.2 | Term | Hip total replacement |
E.1.2 | System Organ Class | 100000004865 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary hypothesis for this trial is that denosumab compared with placebo is effective in preventing periprosthetic bone loss in the proximal femur of female patients after total hip replacement |
Tutkimuksen hypoteesina on, että denosumabi voi estää paikallista luukatoa proteesin varren ympärillä naispotilailla lonkan tekonivelleikkauksen jälkeen |
|
E.2.2 | Secondary objectives of the trial |
The secondary hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration) of cementless hip prosthesis and prevents delayed bonding in osteoporotic postmenopausal women |
Toisena hypoteesina on, että denosumabi voi edistää proteesin kiinnittymistä ja estää proteesin hidastuneen kiinnittymisen osteoporoosia sairastavilla postmenopausaalisilla potilailla. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Postmenopausal women, age: ≥ 60 years to ≤ 85 years at randomization
• Degenerative primary hip OA as the indication of hip replacement
• Signed informed consent
|
• Postmenopausaaliset naiset (ikä 60-85 vuotta)
• Lonkan degeneratiivinen nivelrikko
• Allekirjoitettu suostumuskaavake
|
|
E.4 | Principal exclusion criteria |
• Presence of severe osteoporosis (T-score less than -4.0)
• Presence of Dorr C-type geometric change of the proximal femur
• Evidence of secondary osteoporosis
• Clinical or laboratory evidence of hepatic disease
• Laboratory evidence of hypocalcaemia
• Vitamin D deficiency (serum 25-OH(D) < 12 ng/mL)
• Disorders of parathyroid function
• Uncontrolled hyperthyroidism or hypothyroidism
• History of malignancy, radiotherapy or chemotherapy for malignancy (except basal cell carcinoma of the skin) within the last 5 years
• History of osteonecrosis of the jaw
• History of recent tooth extraction or other dental surgery and/or invasive dental work planned in the next 2 years
• Severe asthma or chronic obstructive pulmonary disease
• Use within 12 months of drugs that affect bone metabolism such as ant-osteoporotic agents (including SERMS), estrogens, testosterone, and anti-epileptics
• Rheumatoid arthritis or any other inflammatory arthritis
• History of skeletal disorder, such as Paget’s disease or osteomalasia
• Alcohol abuse
• General
o Mental, neurological or other conditions that may affect the ability to perform functional or clinical assessments required by the protocol
o Subjects with known sensitivity or intolerance to any of the products to be administered
o Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge
o Any other condition that, in the judgement of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
|
• Vaikea osteoporoosi (T-score alle -4.0)
• Dorr C tyyppinen reisiluun yläosan muoto
• Sekundaarinen osteoporoosi
• Maksasairaus
• Hypocalcaemia
• D-vitamiinin puutostila
• Lisäkilpirauhasen sairaus
• Hoitamaton kilpirauhasen sairaus
• Aiemmin sairastettu syöpä/sädehoito/sytostaattihoito
• Leukaluun verenkiertohäiriö
• Tuore hampaanpoisto tai odotettavissa oleva hammaskirurginen toimenpide
• Vaikea astma tai keuhkoahtaumasairaus
• Luustoon vaikuttavien lääkeaineiden käyttö viimeisen 12 kk aikana
• Nivelreuma tai muu tulehduksellinen nivelsairaus
• Luustosairaus, kuten Pagetin tauti tai osteomalasia
• Alkoholin liikakäyttö
• Muita syitä
o Mielenterveysongelma tai toiminnallinen vika, joka vaikeuttaa tutkimusmenetelmien soveltamista toipumisen arvioinnissa
o Lääkeaine tai muu allergia
o Epävarmuus potilaan osallistumisesta pitkäaikaisseurantaan
o Muu syy, joka tutkijan mielestä voi vaikeuttaa henkilön osallistumista tutkimukseen
|
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the percent change from baseline in periprosthetic BMD of the proximal femur |
Luuntiheyden muutos lonkkaproteesin reisikomponentin ympärillä |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The change from baseline in three-dimensional translational and rotatory migration of the femoral stem |
Lonkan tekonivelen reisikomponentin mikroliike seurannan aikana |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Viimeisen potilaan viimeinen käynti |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |