Ensayo clínico aleatorizado, controlado con placebo, en fase III, para evaluar la seguridad y la eficacia de odanacatib (MK-0822) en cuanto a la reducción del riesgo de fractura en mujeres posmenopáusicas con osteoporosis tratadas con vitamina D y calcio.A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of MK-0822 to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

Phase 1

• Conditions: Osteoporosis postmenopaúsicaPostmenopausal Osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2007-002693-66-ES
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-15
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 16300

Inclusion Criteria

1.Patient is a woman and is >= 65 years of age on the day of signing informed consent.
2.Patient meets one of the following:
a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-2.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR -
c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score <=-2.5 at either the total hip or femoral neck site.
3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
;
1.Patient is a woman and is >= 65 years of age on the day of signing informed consent.
2.Patient meets one of the following:
a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-2.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR -
c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score <=-2.5 at either the total hip or femoral neck site.
3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
;
1.Patient is a woman and is >= 65 years of age on the day of signing informed consent.
2.Patient meets one of the following:
a)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
b)Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-2.5 at either the total hip or femoral neck site, BMD T-score >=-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR -
c)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score <=-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). - OR-
d)Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score <=-2.5 at either the total hip or femoral neck site.
3.The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
4.Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Exclusion Criteria

1)Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
2)Patient has had a prior hip fracture.
3)Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
4)Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
5)Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
;
1)Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
2)Patient has had a prior hip fracture.
3)Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
4)Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
5)Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
;
1)Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
2)Patient has had a prior hip fracture.
3)Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
4)Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
5)Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified