drug · small molecule

FOSAMAX PLUS D

updated 3mo ago

by $OGN Organon & Co.🔗 ChEMBL

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Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 2 investigational indications.

targets

Farnesyl pyrophosphate synthase

all catalysts(0)

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Trials studying FOSAMAX PLUS D

phase3A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)completedn=454
phase3A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)completedn=936
phase3A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)completedn=717
phase3A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)completedn=515
phase4Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)completedn=343
phase3Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)completedn=200

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brand

FOSAMAX PLUS D

trade names

Alendronate sodium, Alendronate sodium component of fosamax plus d, Binosto, Fosamax

generic

ALENDRONATE SODIUM

MOA

12.1 Mechanism of Action Alendronate Sodium Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [ 3 H]alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ 3 H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover (i.e., the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass. Cholecalciferol Vitamin D 3 is produced in the skin by photochemical conversion of 7-dehydrocholesterol to previtamin D 3 by ultraviolet light. This is followed by non-enzymatic isomerization to vitamin D 3 . In the absence of adequate sunlight exposure, vitamin D 3 is an essential dietary nutrient. Vitamin D 3 in skin and dietary vitamin D 3 (absorbed into chylomicrons) is converted to 25-hydroxyvitamin D 3 in the liver. Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D 3 (calcitriol) in the kidney is stimulated by both parathyroid hormone and hypophosphatemia. The principal action of 1,25-dihydroxyvitamin D 3 is to increase intestinal absorption of both calcium an

indication

1 INDICATIONS AND USAGE FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitations of use : FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. ( 1.3 ) Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1) .] 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis FOSAMAX PLUS D is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2) ] . 1.3 Important Limitations of Use FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Data sources

ClinicalTrials.gov · OpenTargets

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drug · small molecule

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FOSAMAX PLUS D

updated 3mo ago

by $OGN Organon & Co.🔗 ChEMBL

community read0 votes

🐶 often sniffed alongside

top 7

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 2 investigational indications.

targets

Farnesyl pyrophosphate synthase

all catalysts(0)

nothing on the calendar yet

Trials studying FOSAMAX PLUS D

phase3A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)completedn=454
phase3A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)completedn=936
phase3A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)completedn=717
phase3A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)completedn=515
phase4Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)completedn=343
phase3Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)completedn=200

News(0)

no news has mentioned this drug yet

brand

FOSAMAX PLUS D

trade names

Alendronate sodium, Alendronate sodium component of fosamax plus d, Binosto, Fosamax

generic

ALENDRONATE SODIUM

MOA

indication

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 5m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

FOSAMAX PLUS D

🐶 often sniffed alongside

targets

all catalysts(0)

Trials studying FOSAMAX PLUS D

News(0)

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FOSAMAX PLUS D

🐶 often sniffed alongside

targets

all catalysts(0)

Trials studying FOSAMAX PLUS D

News(0)

Report a data issue

comments(0)