A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis

B Clemmesen, Pernille Ravn, B Zegels, A N Taquet, C Christiansen, J Y Reginster

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

This paper presents the results of a two-center, double-masked, placebo-controlled, randomized, oral-dose study of risedronate treatment in postmenopausal osteoporosis. Patients had at least one, but no more than four prevalent vertebral fractures at baseline. They received either 2.5 mg continuous risedronate, 2.5 mg cyclic risedronate, or placebo for 2 years. Both risedronate and placebo were formulated as hard gelatin capsules. All women furthermore received a daily calcium supplement of 1 g which was taken separately from the study drug. During the 1-year of follow-up, all women received only a daily calcium supplement of 1 g. A total of 132 patients were enrolled (44 in each treatment group), of which 73% completed the 2-year treatment period and 70% all 3 years. Generally the outcome of the study was negative. Lumbar spine bone mineral density (BMD) increased 1.2% (NS) and 0.8% (NS) and after 2 and 3 years in the group treated with continuous risedronate, 1.7% (NS) and 2.3% (p < 0.05) in the group treated with cyclic risedronate, and 0.6% (NS) and 1.7% (NS) in the placebo group. BMD in the femoral neck increased 2.9% (p < 0.05) and 0.9% (NS) after 2 and 3 years in the group treated with continuous risedronate, 1.3% (NS) and 2.4% (p < 0.01) in the group treated with cyclic risedronate, and 1.3% (NS) and 2.6% (p < 0.01) in the placebo group. The differences between all three groups in spinal and femoral BMD after 2 years were not statistically significant, but reached statistical significance after 3 years (p < 0.01) in the femoral neck. Only minor changes were observed in the measured markers of bone turnover. Both the incidence and rate of new vertebral fractures showed no overall differences between the groups. The distribution of adverse events was similar across treatment groups. None of the serious adverse events were considered causally related to risedronate. The lack of effect shown in the present study may be explained by insufficient dose regimen and/or impaired absorption from the intestinal tract. Further investigations (ongoing phase III trials) are needed to define future dose regimens in order to validate the effect on bone mass, fracture rate and biochemical markers. In these studies another formulation of the drug and other dosing instructions are used.

Original languageEnglish
JournalOsteoporosis International
Volume7
Issue number5
Pages (from-to)488-95
Number of pages8
ISSN0937-941X
Publication statusPublished - 1997

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Postmenopausal Osteoporosis
Placebos
Bone Density
Femur Neck
Risedronate Sodium
NE 58095
Drug Compounding
Bone Fractures
Gelatin
Outcome Assessment (Health Care)
Incidence

Keywords

  • Aged
  • Aged, 80 and over
  • Bone Density
  • Bone and Bones
  • Calcium Channel Blockers
  • Double-Blind Method
  • Etidronic Acid
  • Female
  • Femur Neck
  • Follow-Up Studies
  • Humans
  • Lumbar Vertebrae
  • Middle Aged
  • Osteoporosis, Postmenopausal
  • Spinal Fractures

Cite this

Clemmesen, B., Ravn, P., Zegels, B., Taquet, A. N., Christiansen, C., & Reginster, J. Y. (1997). A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. Osteoporosis International, 7(5), 488-95.
Clemmesen, B ; Ravn, Pernille ; Zegels, B ; Taquet, A N ; Christiansen, C ; Reginster, J Y. / A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. In: Osteoporosis International. 1997 ; Vol. 7, No. 5. pp. 488-95.
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abstract = "This paper presents the results of a two-center, double-masked, placebo-controlled, randomized, oral-dose study of risedronate treatment in postmenopausal osteoporosis. Patients had at least one, but no more than four prevalent vertebral fractures at baseline. They received either 2.5 mg continuous risedronate, 2.5 mg cyclic risedronate, or placebo for 2 years. Both risedronate and placebo were formulated as hard gelatin capsules. All women furthermore received a daily calcium supplement of 1 g which was taken separately from the study drug. During the 1-year of follow-up, all women received only a daily calcium supplement of 1 g. A total of 132 patients were enrolled (44 in each treatment group), of which 73{\%} completed the 2-year treatment period and 70{\%} all 3 years. Generally the outcome of the study was negative. Lumbar spine bone mineral density (BMD) increased 1.2{\%} (NS) and 0.8{\%} (NS) and after 2 and 3 years in the group treated with continuous risedronate, 1.7{\%} (NS) and 2.3{\%} (p < 0.05) in the group treated with cyclic risedronate, and 0.6{\%} (NS) and 1.7{\%} (NS) in the placebo group. BMD in the femoral neck increased 2.9{\%} (p < 0.05) and 0.9{\%} (NS) after 2 and 3 years in the group treated with continuous risedronate, 1.3{\%} (NS) and 2.4{\%} (p < 0.01) in the group treated with cyclic risedronate, and 1.3{\%} (NS) and 2.6{\%} (p < 0.01) in the placebo group. The differences between all three groups in spinal and femoral BMD after 2 years were not statistically significant, but reached statistical significance after 3 years (p < 0.01) in the femoral neck. Only minor changes were observed in the measured markers of bone turnover. Both the incidence and rate of new vertebral fractures showed no overall differences between the groups. The distribution of adverse events was similar across treatment groups. None of the serious adverse events were considered causally related to risedronate. The lack of effect shown in the present study may be explained by insufficient dose regimen and/or impaired absorption from the intestinal tract. Further investigations (ongoing phase III trials) are needed to define future dose regimens in order to validate the effect on bone mass, fracture rate and biochemical markers. In these studies another formulation of the drug and other dosing instructions are used.",
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Clemmesen, B, Ravn, P, Zegels, B, Taquet, AN, Christiansen, C & Reginster, JY 1997, 'A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis', Osteoporosis International, vol. 7, no. 5, pp. 488-95.

A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis. / Clemmesen, B; Ravn, Pernille; Zegels, B; Taquet, A N; Christiansen, C; Reginster, J Y.

In: Osteoporosis International, Vol. 7, No. 5, 1997, p. 488-95.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - A 2-year phase II study with 1-year of follow-up of risedronate (NE-58095) in postmenopausal osteoporosis

AU - Clemmesen, B

AU - Ravn, Pernille

AU - Zegels, B

AU - Taquet, A N

AU - Christiansen, C

AU - Reginster, J Y

PY - 1997

Y1 - 1997

N2 - This paper presents the results of a two-center, double-masked, placebo-controlled, randomized, oral-dose study of risedronate treatment in postmenopausal osteoporosis. Patients had at least one, but no more than four prevalent vertebral fractures at baseline. They received either 2.5 mg continuous risedronate, 2.5 mg cyclic risedronate, or placebo for 2 years. Both risedronate and placebo were formulated as hard gelatin capsules. All women furthermore received a daily calcium supplement of 1 g which was taken separately from the study drug. During the 1-year of follow-up, all women received only a daily calcium supplement of 1 g. A total of 132 patients were enrolled (44 in each treatment group), of which 73% completed the 2-year treatment period and 70% all 3 years. Generally the outcome of the study was negative. Lumbar spine bone mineral density (BMD) increased 1.2% (NS) and 0.8% (NS) and after 2 and 3 years in the group treated with continuous risedronate, 1.7% (NS) and 2.3% (p < 0.05) in the group treated with cyclic risedronate, and 0.6% (NS) and 1.7% (NS) in the placebo group. BMD in the femoral neck increased 2.9% (p < 0.05) and 0.9% (NS) after 2 and 3 years in the group treated with continuous risedronate, 1.3% (NS) and 2.4% (p < 0.01) in the group treated with cyclic risedronate, and 1.3% (NS) and 2.6% (p < 0.01) in the placebo group. The differences between all three groups in spinal and femoral BMD after 2 years were not statistically significant, but reached statistical significance after 3 years (p < 0.01) in the femoral neck. Only minor changes were observed in the measured markers of bone turnover. Both the incidence and rate of new vertebral fractures showed no overall differences between the groups. The distribution of adverse events was similar across treatment groups. None of the serious adverse events were considered causally related to risedronate. The lack of effect shown in the present study may be explained by insufficient dose regimen and/or impaired absorption from the intestinal tract. Further investigations (ongoing phase III trials) are needed to define future dose regimens in order to validate the effect on bone mass, fracture rate and biochemical markers. In these studies another formulation of the drug and other dosing instructions are used.

AB - This paper presents the results of a two-center, double-masked, placebo-controlled, randomized, oral-dose study of risedronate treatment in postmenopausal osteoporosis. Patients had at least one, but no more than four prevalent vertebral fractures at baseline. They received either 2.5 mg continuous risedronate, 2.5 mg cyclic risedronate, or placebo for 2 years. Both risedronate and placebo were formulated as hard gelatin capsules. All women furthermore received a daily calcium supplement of 1 g which was taken separately from the study drug. During the 1-year of follow-up, all women received only a daily calcium supplement of 1 g. A total of 132 patients were enrolled (44 in each treatment group), of which 73% completed the 2-year treatment period and 70% all 3 years. Generally the outcome of the study was negative. Lumbar spine bone mineral density (BMD) increased 1.2% (NS) and 0.8% (NS) and after 2 and 3 years in the group treated with continuous risedronate, 1.7% (NS) and 2.3% (p < 0.05) in the group treated with cyclic risedronate, and 0.6% (NS) and 1.7% (NS) in the placebo group. BMD in the femoral neck increased 2.9% (p < 0.05) and 0.9% (NS) after 2 and 3 years in the group treated with continuous risedronate, 1.3% (NS) and 2.4% (p < 0.01) in the group treated with cyclic risedronate, and 1.3% (NS) and 2.6% (p < 0.01) in the placebo group. The differences between all three groups in spinal and femoral BMD after 2 years were not statistically significant, but reached statistical significance after 3 years (p < 0.01) in the femoral neck. Only minor changes were observed in the measured markers of bone turnover. Both the incidence and rate of new vertebral fractures showed no overall differences between the groups. The distribution of adverse events was similar across treatment groups. None of the serious adverse events were considered causally related to risedronate. The lack of effect shown in the present study may be explained by insufficient dose regimen and/or impaired absorption from the intestinal tract. Further investigations (ongoing phase III trials) are needed to define future dose regimens in order to validate the effect on bone mass, fracture rate and biochemical markers. In these studies another formulation of the drug and other dosing instructions are used.

KW - Aged

KW - Aged, 80 and over

KW - Bone Density

KW - Bone and Bones

KW - Calcium Channel Blockers

KW - Double-Blind Method

KW - Etidronic Acid

KW - Female

KW - Femur Neck

KW - Follow-Up Studies

KW - Humans

KW - Lumbar Vertebrae

KW - Middle Aged

KW - Osteoporosis, Postmenopausal

KW - Spinal Fractures

M3 - Journal article

C2 - 9425508

VL - 7

SP - 488

EP - 495

JO - Osteoporosis International

JF - Osteoporosis International

SN - 0937-941X

IS - 5

ER -