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Study · Randomized controlled trial · 2024

10 results

Oral daily PTH(1-34) tablets (EB613) in postmenopausal women with low BMD or osteoporosis: a randomized, placebo-controlled, 6-month, phase 2 study.

Tripto-Shkolnik L, Szalat A, Tsvetov G, Rouach V, Sternberg C, Hoppe A, Burshtein G, Galitzer H, Toledano M, Harari G, Santora AC, Cosman F

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research1 Jul 2024Cited by 14 (Europe PMC)

PMID38578978 (opens in a new tab)DOI10.1093/jbmr/zjae057 (opens in a new tab)PepBankPUB-38578978
Publisher pagePubMedAsk about this study
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Summary

Anabolic treatment is indicated for high and very-high risk patients with osteoporosis, but acceptance is limited because current anabolic medications require subcutaneous injections. The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis. In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily. Biochemical markers were assessed at 1, 2, 3, and 6 mo and BMD of LS, TH, and FN was measured at 6 mo. Biochemical marker changes were dose dependent with minimal or no effect at the 2 lowest doses. At the highest dose (2.5 mg once daily), serum PINP and OC levels increased 30% within 1 mo after oral PTH initiation (P < .0001), remained elevated through 3 mo, and were back to baseline at 6 mo. In contrast, serum CTX levels declined 16% and 21% below baseline at 3 and 6 mo, respectively (both P ≤ .02). At 6 mo, 2.5 mg tablets increased mean BMD vs placebo of the LS by 2.7%, TH by 1.8%, and FN by 2.8% (all P ≤ .01). There were no drug-related serious adverse events. The most common adverse events were headache, nausea, and dizziness. In contrast to subcutaneous PTH, the oral PTH tablet appears to increase BMD rapidly by the dual mechanism of stimulating formation and inhibiting bone resorption. This might be the first effective oral anabolic alternative to subcutaneous administration for the treatment of low BMD or osteoporosis.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women with low BMD or osteoporosis, biochemical marker changes with oral PTH were dose dependent, with minimal or no effects at the two lowest doses.

    In plain wordsIn women with low bone density or osteoporosis, marker changes depended on oral PTH dose, with minimal or no effects at the lowest doses.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    No significant changeLow-dose biochemical marker response
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    0.5 or 1.0 mg daily · oral · 6 monthsAs given in this study (human).

    Source sentences

    Summary
    Biochemical marker changes were dose dependent with minimal or no effect at the 2 lowest doses.
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH increased PINP 30% within one month, maintained elevation through three months, and returned to baseline at six months.

    In plain wordsIn postmenopausal women, oral PTH initially raised PINP versus baseline, but PINP returned to baseline at six months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    MixedPINP time course
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    PINP increase
    30%
    within 1 month

    Source sentences

    Summary
    At the highest dose (2.5 mg once daily), serum PINP and OC levels increased 30% within 1 mo after oral PTH initiation (P < .0001), remained elevated through 3 mo, and were back to baseline at 6 mo.
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH increased osteocalcin 30% within one month, maintained elevation through three months, and returned to baseline at six months.

    In plain wordsIn postmenopausal women, oral PTH initially raised osteocalcin versus baseline, but osteocalcin returned to baseline at six months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    MixedOsteocalcin time course
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    Osteocalcin increase
    30%
    within 1 month

    Source sentences

    Summary
    At the highest dose (2.5 mg once daily), serum PINP and OC levels increased 30% within 1 mo after oral PTH initiation (P < .0001), remained elevated through 3 mo, and were back to baseline at 6 mo.
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH reduced serum CTX 16% below baseline at three months.

    In plain wordsIn postmenopausal women, oral PTH reduced a bone resorption marker below baseline at three months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseCTX at three months
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    CTX reduction
    16%
    3 months

    Source sentences

    Summary
    In contrast, serum CTX levels declined 16% and 21% below baseline at 3 and 6 mo, respectively (both P ≤ .02).
    3 context sentences
    Summary · context
    At the highest dose (2.5 mg once daily), serum PINP and OC levels increased 30% within 1 mo after oral PTH initiation (P < .0001), remained elevated through 3 mo, and were back to baseline at 6 mo.
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH reduced serum CTX 21% below baseline at six months.

    In plain wordsIn postmenopausal women, oral PTH reduced a bone resorption marker below baseline at six months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    DecreaseCTX at six months
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    CTX reduction
    21%
    6 months

    Source sentences

    Summary
    In contrast, serum CTX levels declined 16% and 21% below baseline at 3 and 6 mo, respectively (both P ≤ .02).
    3 context sentences
    Summary · context
    At the highest dose (2.5 mg once daily), serum PINP and OC levels increased 30% within 1 mo after oral PTH initiation (P < .0001), remained elevated through 3 mo, and were back to baseline at 6 mo.
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH increased lumbar spine BMD by 2.7% versus placebo at six months.

    In plain wordsIn postmenopausal women, oral PTH increased lower spine bone density more than placebo at six months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseLumbar spine BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    BMD difference
    2.7%
    lumbar spine versus placebo

    Source sentences

    Summary
    At 6 mo, 2.5 mg tablets increased mean BMD vs placebo of the LS by 2.7%, TH by 1.8%, and FN by 2.8% (all P ≤ .01).
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH increased total hip BMD by 1.8% versus placebo at six months.

    In plain wordsIn postmenopausal women, oral PTH increased total hip bone density more than placebo at six months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseTotal hip BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    BMD difference
    1.8%
    total hip versus placebo

    Source sentences

    Summary
    At 6 mo, 2.5 mg tablets increased mean BMD vs placebo of the LS by 2.7%, TH by 1.8%, and FN by 2.8% (all P ≤ .01).
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In postmenopausal women, oral PTH increased femoral neck BMD by 2.8% versus placebo at six months.

    In plain wordsIn postmenopausal women, oral PTH increased femoral neck bone density more than placebo at six months.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    IncreaseFemoral neck BMD
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2.5 mg daily · oral · 6 monthsAs given in this study (human).

    Measurements

    BMD difference
    2.8%
    femoral neck versus placebo

    Source sentences

    Summary
    At 6 mo, 2.5 mg tablets increased mean BMD vs placebo of the LS by 2.7%, TH by 1.8%, and FN by 2.8% (all P ≤ .01).
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  9. 09HumanRandomized controlled trialSafety outcome

    In postmenopausal women receiving oral PTH, no drug-related serious adverse events occurred.

    In plain wordsIn postmenopausal women receiving oral PTH, no drug-related serious adverse events occurred.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableDrug-related serious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oral · 6 monthsAs given in this study (human).

    Source sentences

    Summary
    There were no drug-related serious adverse events.
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.
  10. 10HumanRandomized controlled trialSafety outcome

    In postmenopausal women in the oral PTH trial, headache, nausea and dizziness were the most common adverse events.

    In plain wordsIn postmenopausal women taking oral PTH tablets, headache, nausea and dizziness were the most common side effects.

    Peptide
    Teriparatide (PTH 1-34)
    Outcome
    Not applicableMost common adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oral · 6 monthsAs given in this study (human).

    Source sentences

    Summary
    The most common adverse events were headache, nausea, and dizziness.
    2 context sentences
    Summary · context
    The purpose of this study was to assess the effects of a novel orally administered PTH tablet on serum markers of bone formation (PINP and osteocalcin), bone resorption (crosslinked C-telopeptide [CTX]), BMD, and safety in postmenopausal women with low BMD or osteoporosis.
    Summary · context
    In this 6-mo, double-blind, placebo-controlled study, 161 patients were randomized to oral PTH tablets containing 0.5, 1.0, 1.5, or 2.5 mg or placebo daily.

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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