A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group.

Chesnut CH 3rd, Silverman S, Andriano K, Genant H, Gimona A, Harris S, Kiel D, LeBoff M, Maricic M, Miller P, Moniz C, Peacock M, Richardson P, Watts N, Baylink D

The American journal of medicine1 Sept 2000Cited by 585 (Europe PMC)

PMID10996576DOI10.1016/s0002-9343(00)00490-3PepBankPUB-10996576

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In postmenopausal women with osteoporosis, salmon calcitonin nasal spray at 200 IU daily reduced new vertebral fracture risk by 33% versus placebo.
In plain wordsIn postmenopausal women with osteoporosis, salmon calcitonin nasal spray at 200 IU daily reduced new spine fracture risk by 33% versus placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseNew vertebral fractures
Study
n = 557
Comparator
Placebo
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
200 IU daily · intranasal · 5 yearsAs given in this study (human).
Measurements
Fractures
51 of 287
200 IU
Fractures
70 of 270
placebo
Relative risk
0.67
200 IU versus placebo
95% CI
0.47 to 0.97
relative risk
P
0.03
between groups
Source sentences
Summary
The 200-IU dose of salmon calcitonin nasal spray significantly reduced the risk of new vertebral fractures by 33% compared with placebo [200 IU: 51 of 287, placebo: 70 of 270, relative risk (RR) = 0.67, 95% confidence interval (CI): 0.47- to 0.97, P = 0.03].
4 context sentences(design, population, supporting numbers)
Summary · context
The primary efficacy endpoint was the risk of new vertebral fractures in the salmon calcitonin nasal spray 200-IU group compared with the placebo group.
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657601
02HumanRandomized controlled trialEfficacy outcome
In women with prevalent vertebral fractures, salmon calcitonin reduced new vertebral fracture risk by 36% versus placebo.
In plain wordsIn women with existing spine fractures, salmon calcitonin reduced new spine fracture risk by 36% versus placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseNew vertebral fractures with prevalent fractures
Study
n = 817
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · intranasal · 5 yearsAs given in this study (human).
Measurements
Relative risk
0.64
prevalent fracture subgroup
95% CI
0.43 to 0.96
relative risk
P
0.03
between groups
Source sentences
Summary
In the 817 women with one to five prevalent vertebral fractures at enrollment, the risk was reduced by 36% (RR = 0.64, 95% CI: 0.43- to 0.96, P = 0.03).
4 context sentences(design, population, supporting numbers)
Summary · context
The 200-IU dose of salmon calcitonin nasal spray significantly reduced the risk of new vertebral fractures by 33% compared with placebo [200 IU: 51 of 287, placebo: 70 of 270, relative risk (RR) = 0.67, 95% confidence interval (CI): 0.47- to 0.97, P = 0.03].
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657602
03HumanRandomized controlled trialEfficacy outcome
In postmenopausal osteoporosis, salmon calcitonin at 100 IU did not significantly reduce vertebral fractures versus placebo.
In plain wordsIn postmenopausal osteoporosis, salmon calcitonin at 100 IU did not significantly reduce spine fractures versus placebo.
Peptide
Calcitonin-salmon
Outcome
No significant changeNew vertebral fractures
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100 IU daily · intranasal · 5 yearsAs given in this study (human).
Measurements
Relative risk
0.85
100 IU versus placebo
95% CI
0.6 to 1.21
relative risk
Source sentences
Summary
The reductions in vertebral fractures in the 100-IU (RR = 0.85, 95% CI: 0.60- to 1.21) and the 400-IU (RR = 0.84, 95% CI: 0.59- to 1.18) groups were not significantly different from placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657603
04HumanRandomized controlled trialEfficacy outcome
In postmenopausal osteoporosis, salmon calcitonin at 400 IU did not significantly reduce vertebral fractures versus placebo.
In plain wordsIn postmenopausal osteoporosis, salmon calcitonin at 400 IU did not significantly reduce spine fractures versus placebo.
Peptide
Calcitonin-salmon
Outcome
No significant changeNew vertebral fractures
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
400 IU daily · intranasal · 5 yearsAs given in this study (human).
Measurements
Relative risk
0.84
400 IU versus placebo
95% CI
0.59 to 1.18
relative risk
Source sentences
Summary
The reductions in vertebral fractures in the 100-IU (RR = 0.85, 95% CI: 0.60- to 1.21) and the 400-IU (RR = 0.84, 95% CI: 0.59- to 1.18) groups were not significantly different from placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657604
05HumanRandomized controlled trialEfficacy outcome
In postmenopausal osteoporosis, salmon calcitonin at 200 IU suppressed serum C-telopeptide by 12% versus placebo.
In plain wordsIn postmenopausal osteoporosis, salmon calcitonin at 200 IU reduced a bone breakdown marker by 12% versus placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseSerum C-telopeptide
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
200 IU daily · intranasal · 5 yearsAs given in this study (human).
Measurements
C-telopeptide suppression
12%
200 IU versus placebo
P
< 0.01
200 IU
Source sentences
Summary
Bone turnover was inhibited, as shown by suppression of serum type-I collagen cross-linked telopeptide (C-telopeptide) by 12% in the 200-IU group (P <0.01) and by 14% in the 400-IU group (P<0.01) as compared with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657606
06HumanRandomized controlled trialEfficacy outcome
In postmenopausal osteoporosis, salmon calcitonin at 400 IU suppressed serum C-telopeptide by 14% versus placebo.
In plain wordsIn postmenopausal osteoporosis, salmon calcitonin at 400 IU reduced a bone breakdown marker by 14% versus placebo.
Peptide
Calcitonin-salmon
Outcome
DecreaseSerum C-telopeptide
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
400 IU daily · intranasal · 5 yearsAs given in this study (human).
Measurements
C-telopeptide suppression
14%
400 IU versus placebo
P
< 0.01
400 IU
Source sentences
Summary
Bone turnover was inhibited, as shown by suppression of serum type-I collagen cross-linked telopeptide (C-telopeptide) by 12% in the 200-IU group (P <0.01) and by 14% in the 400-IU group (P<0.01) as compared with placebo.
3 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657607
07HumanNon-randomized trialEfficacy outcome
In postmenopausal osteoporosis, lumbar BMD increased significantly from baseline in all salmon calcitonin groups.
In plain wordsIn postmenopausal osteoporosis, lower spine bone density increased significantly from baseline in all salmon calcitonin groups.
Peptide
Calcitonin-salmon
Outcome
IncreaseLumbar spine BMD
Study
n: not reported in source
Outcome group
Bone and joint · Musculoskeletal
Studied dose
100, 200, or 400 IU daily · intranasal · 5 yearsAs given in this study (human).
Measurements
Lumbar BMD increase
1 to 1.5%
all active treatment groups
P
< 0.01
versus baseline, all active treatment groups
Source sentences
Summary
Lumbar spine bone mineral density increased significantly from baseline (1% to 1. 5%, P<0.01) in all active treatment groups.
3 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis.
Summary · context
A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily.
Summary · context
All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily.
Report a problemFND-1099657605

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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