EUCTR2010-021009-19-GB进行中（未招募）1 期
Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A two year open label single arm study of teriparatide in secondary care. - Teriparatide Treatment in Postmenopausal Women: Mechanism of Action
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects must:
- •- Have a BMD T-score (at the lumbar spine or total hip) of less than or equal to -2.5
- •- Be female
- •- Be at least 5 years post menopausal (more than 5 years since their last menstrual period) but <85 years old.
- •- Be ambulatory
- •- Be able and willing to participate in the study and provide written informed consent
- •- Have a serum 25 (OH)2 vitamin D3 >50 nmol/L (after vitamin D3 loading)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be admitted to the study if they exhibit any of the following:
- •- Evidence of a clinically significant organic disease which could prevent the patient from completing the study
- •- A BMI less than 18 or greater than 35
- •- Abuse of alcohol or use illicit drugs (information obtained from medical history) or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
- •- Any history of cancer within the past 5 years excluding skin cancer non melanomas
- •- Any history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health including Paget’s disease of bone
- •- Chronic renal disease (as defined by an estimated glomerular filtration rate of = 30mL/min)
- •- Acute or chronic hepatic disease
- •- Malabsorption syndromes
- •- Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- •- Hyperparathyroidism
- •- Hypocalcemia or hypercalcemia
- •- Osteomalacia
- •- Cushing’s syndrome
- •- Current use of glucocorticoid therapy
- •- A corrected serum calcium less than 2.2 mmol/L and a PTH above 100ng/L (that persists after testing and treatment for vitamin D deficiency)
- •- A history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck
- •- Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator
- •- Any previous use of bisphosphonate
- •- Use any of the following medications within 12 months of starting study drug
- •- Any fluoride with the exception of use for oral hygiene
- •- Strontium Ranelate
- •- Other bone agents (e.g. SERM, isoflavones, HRT)
- •- Participation in another clinical trial involving active therapy 3 months prior to enrolment
- •- Less than 5 years since menopause
- •- Bilateral fractures in the measurement regions (hip, tibia and forearm).
- •- Recent fracture within the last 12 months
- •- Prior radiation therapy which may involve the skeleton
- •- Hypersensitivity to teriparatide or any of its exipients
- •- Unexplained elevations of alkaline phosphatase
- •- Any known contraindication to the use of teriparatide.
研究者
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Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of ActionOsteoporosisNCT01293292Sheffield Teaching Hospitals NHS Foundation Trust19
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